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 |