MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-09 for YAG GRP4 SCALPEL PROBE GRP 4 manufactured by Surgical Laser Tech.
[12119]
During endoscopic lysis of pelvic adhesions, the tip of the scalpel probe broke off in the pt's pelvis and could not be found. Noted to possibly be in trocars or in wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22689 |
| MDR Report Key | 22689 |
| Date Received | 1995-06-09 |
| Date of Report | 1995-04-10 |
| Date of Event | 1995-02-02 |
| Date Facility Aware | 1995-02-02 |
| Date Reported to Mfgr | 1995-04-18 |
| Date Added to Maude | 1995-06-22 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | ATTORNEY |
| 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 | YAG GRP4 SCALPEL PROBE |
| Generic Name | SCALPEL PROBE |
| Product Code | LLW |
| Date Received | 1995-06-09 |
| Model Number | GRP 4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22883 |
| Manufacturer | SURGICAL LASER TECH |
| Manufacturer Address | OAK PA 19456 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-06-09 |