MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-05 for LAPAROSCOPIC TROCAR SLEEVE 8351.07 manufactured by R Wolf, Gmbh.
[6887]
During a laparoscopic procedure, a small section of fiberglass material broke off of the tip. The fragment was retrieved from the pt's abdomen. No other problems were reported. The piece was discarded by the user facility. Device labeled for single use. Patient medical status prior to event: unknown. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1994-09065 |
| MDR Report Key | 9386 |
| Date Received | 1994-08-05 |
| Date of Report | 1994-07-22 |
| Date of Event | 1994-07-11 |
| Date Facility Aware | 1994-07-19 |
| Report Date | 1994-07-22 |
| Date Reported to FDA | 1994-07-22 |
| Date Reported to Mfgr | 1994-07-22 |
| Date Added to Maude | 1994-12-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPAROSCOPIC TROCAR SLEEVE |
| Generic Name | SAME |
| Product Code | FBQ |
| Date Received | 1994-08-05 |
| Model Number | 8351.07 |
| Catalog Number | 8351.07 |
| Lot Number | NONE |
| ID Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 9043 |
| Manufacturer | R WOLF, GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-08-05 |