MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for JARIT 600-318 manufactured by Integra York Pa, Inc..
[77218548]
Patient Sequence No: 1, Text Type: N, H10
[77218549]
Small insulation defect at tip of left l hook caused an arc of electricity away from the site intended to be cauterized during a laparoscopic cholecystectomy procedure. Manufacturer response for jarit l hook cautery probe, jarit l-hook electrocautery probe (per site reporter): aware of problem and has replaced all l-hooks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6629773 |
| MDR Report Key | 6629773 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-05-12 |
| Report Date | 2017-05-30 |
| Date Reported to FDA | 2017-05-30 |
| Date Reported to Mfgr | 2017-05-30 |
| Date Added to Maude | 2017-06-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT |
| Generic Name | COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES) |
| Product Code | KNF |
| Date Received | 2017-06-09 |
| Model Number | 600-318 |
| Catalog Number | 600-318 |
| ID Number | 1363487 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA, INC. |
| Manufacturer Address | 589 DAVIES DR. YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |