MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for JARIT 600-290 manufactured by Integra Lifesciences Corporation.
[77551039]
Patient Sequence No: 1, Text Type: N, H10
[77551040]
During a laparoscopic cholecystectomy the surgeon was about to use cautery when the surgeon noted smoldering on the drape covering the patient's left arm and the anesthesiologist immediately put the fire out. The electrocautery cord was burned into two pieces and was near the patient's left hand. The patient's left hand was wrapped in egg crate and pillow case and covered by a drape, part of the drape, pillowcase and egg crate were burned. The patient's hand and fingers were inspected and there was no injury or burn to the area as the fire did not reach the patient. The or tech had inspected the cord prior to the case and did not see any defects or cracks in the insulation. Manufacturer response for monopolar cautery cable, jarit monopolar cautery cable (per site reporter): came to facility and removed product and provide with all new products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6639586 |
| MDR Report Key | 6639586 |
| Date Received | 2017-06-14 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-05-15 |
| Report Date | 2017-05-30 |
| Date Reported to FDA | 2017-05-30 |
| Date Reported to Mfgr | 2017-05-30 |
| Date Added to Maude | 2017-06-14 |
| 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 | 2017-06-14 |
| Catalog Number | 600-290 |
| Lot Number | 100197-141 |
| ID Number | 1363309 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 589 DAVIES DR. YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-14 |