MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for SURGICAL LAPAROSCOPIC GRASPER manufactured by Teleflex Medical.
[182956109]
Instrument broke during surgery. X-ray confirmed no retained foreign objects. Grasper part of the device bent backwards - pulled out of trocar - would not fit back thru the trocar. Pulled everything out together then it broke. Bent inside of the patient. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9817551 |
| MDR Report Key | 9817551 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-27 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL LAPAROSCOPIC GRASPER |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | OCW |
| Date Received | 2020-03-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |