MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for LASER MTRL3 CLMD manufactured by Surgical Laser Technologies.
[17826941]
Patient was admitted to room 6 pavilion operating room for laser laparoscopy and excision of cyst. While on the course of laser usage, the laser tip (mtrl3) fell off the handle and caused a blanching of the bowel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15570 |
| MDR Report Key | 15570 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-06-27 |
| Date of Event | 1994-06-22 |
| Date Facility Aware | 1994-06-22 |
| Report Date | 1994-06-27 |
| Date Reported to Mfgr | 1994-06-27 |
| Date Added to Maude | 1994-08-29 |
| 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 MTRL3 |
| Generic Name | YAG LASER 40/60 #05772 SGT |
| Product Code | LLW |
| Date Received | 1994-07-21 |
| Model Number | CLMD |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15562 |
| Manufacturer | SURGICAL LASER TECHNOLOGIES |
| Manufacturer Address | 200 CRESSON BLVD. OAKS PA 19456 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-21 |