MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-03-31 for CUSA EXCEL 23KHZ TUBING SET C3600 manufactured by Integra Lifesciences (ireland) Limited.
[4499942]
While using the lap (laparoscopic) mode, the tubing set couldn't be closed completely by the suction pinch valve and slight evacuation happened even when releasing the footswitch. Hence, pneumoperitoneum could not be maintained. It was reported that the customer was setting the tubing set correctly to the pinch valve. It was also confirmed that the console had no errors. The customer stated that it seemed that the tube was too stiff to close completely by the pinch valve,. The customer could not use the lap mode during the procedure. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[11788412]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2014-00018 |
| MDR Report Key | 3817629 |
| Report Source | 01,08 |
| Date Received | 2014-03-31 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-03-05 |
| Date Mfgr Received | 2014-03-21 |
| Date Added to Maude | 2014-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL 23KHZ TUBING SET |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2014-03-31 |
| Catalog Number | C3600 |
| Lot Number | 1133555 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
| Manufacturer Address | SRAGH TULLAMORE, CO. OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-31 |