MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-01 for HOOK ELECTRODE 5MM 32CM 600319 manufactured by Integra York, Pa Inc..
[145506632]
The device involved in the reported incident is not yet available for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[145506633]
A customer reported that on (b)(6) 2019, during a laparoscopic cholecystectomy procedure, a 600319 hook electrode 5 mm 32 cm sparked due to the coating peeling off. There was no fire observed. The patient was prepped for surgery and the device was in contact with the patient. There was no surgical delay and no patient injury / death alleged. The action taken after the product problem occurred was that the device was tagged for repair. No other information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00067 |
| MDR Report Key | 8570991 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-05-14 |
| Date Added to Maude | 2019-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOOK ELECTRODE 5MM 32CM |
| Generic Name | ELECTROSURGICAL COAGULATION |
| Product Code | KNF |
| Date Received | 2019-05-01 |
| Returned To Mfg | 2019-04-30 |
| Catalog Number | 600319 |
| Lot Number | 100161-1805 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |