MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-05 for LAPAROSCOPIC INSULATED BLADE & HOOK 600-305 manufactured by Jarit.
[16836]
Pt was admitted for laparoscopic cholescystectomy. After gallbladder removed from gallbladder bed, cautery marks noted on liver where no cautery used. Dr asked that insulation on two instruments used (hook and blade) be checked out. Instruments checked weekly. The instruments were used on one case before this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22188 |
| MDR Report Key | 22188 |
| Date Received | 1995-05-05 |
| Date of Report | 1995-05-05 |
| Date of Event | 1995-04-26 |
| Date Facility Aware | 1995-04-26 |
| Report Date | 1995-05-05 |
| Date Reported to FDA | 1995-05-05 |
| Date Reported to Mfgr | 1995-05-05 |
| Date Added to Maude | 1995-06-05 |
| 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 | LAPAROSCOPIC INSULATED BLADE & HOOK |
| Generic Name | LAPAROSCOPIC INSULATED BLADE & HOOK |
| Product Code | KOA |
| Date Received | 1995-05-05 |
| Returned To Mfg | 1995-05-03 |
| Model Number | 600-305 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22287 |
| Manufacturer | JARIT |
| Manufacturer Address | HAWTHORNE NY 10532 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-05-05 |