MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-15 for LASER TIP GRP-6 * manufactured by Surgical Laser Technologies.
[51370]
During laparoscopy laser procedure-ovarian cystectomy, laser tip broke off. Apparently in pt's abdomen. Surgeon looked for it and irrigated cavity thoroughly. Tip not located. Co notified for inquiry about tip. Used grp-6, 10 watts. Laser time 6 minutes total. Coolant co2-laser set at. 2-. 4.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 92273 |
| MDR Report Key | 92273 |
| Date Received | 1995-02-15 |
| Date of Report | 1994-10-12 |
| Date of Event | 1994-10-06 |
| Date Facility Aware | 1994-10-06 |
| Report Date | 1994-10-12 |
| Date Reported to Mfgr | 1994-10-12 |
| Date Added to Maude | 1997-05-22 |
| 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 |
| 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 | LASER TIP |
| Generic Name | LASER TIP |
| Product Code | LLW |
| Date Received | 1995-02-15 |
| Model Number | GRP-6 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 91148 |
| Manufacturer | SURGICAL LASER TECHNOLOGIES |
| Manufacturer Address | 200 CRESSON BLVD. OAKS PA 19456 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-02-15 |