International safety notice
During surgical procedures in which this device is used, complications due to excessive pneumoperitoneum, such as arrhythmia (brief cardiac arrest), gas embolism, and death, may occur. We received information from an overseas facility that seems to be a possibility. As a result of the investigation, one of the causes of abdominal overpressure is that the software of the device is unable to detect a malfunction of the pressure sensor. I understand that. New software detects pressure sensor failure to reduce potential risks associated with abdominal overpressure. correct the algorithm.
Japan / PMDA Recalls · JPN · Aug 27, 2024
Key facts
| Title | During surgical procedures in which this device is used, complications due to excessive pneumoperitoneum, such as arrhythmia (brief cardiac arrest), gas embolism, and death, may occur. We received information from an overseas facility that seems to be a possibility. As a result of the investigation, one of the causes of abdominal overpressure is that the software of the device is unable to detect a malfunction of the pressure sensor. I understand that. New software detects pressure sensor failure to reduce potential risks associated with abdominal overpressure. correct the algorithm. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Laparoscopic gas pneumoperitoneum device Brand name: High-speed pneumoperitoneum device UHI-4 |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | 7945062, 7843945, 7311633, 7322118, 7946373, 7160926, 7047426, 7749904, 7322774, 7740269, 7211442, 7434362 and 4547 more |
| Date | Aug 27, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1