MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-16 for L-SHAPE HOOK ELECTRODE 5MM32CM 600318 manufactured by Integra York, Pa Inc..
[102626634]
The device was not returned to the manufacturer for physical evaluation, therefore the failure mode could not be confirmed. However, an investigation of the device inspection records was conducted by the manufacturer. There were no deviations or non-conformances during the inspection process. The serial/lot number was not provided therefore a dhr review could not be performed.
Patient Sequence No: 1, Text Type: N, H10
[102626635]
A nurse reported to integra that a 600318 l-shape hook electrode 5mm32cm was used on (b)(6) 2018 during a laparoscopic cholecystectomy. It was stated that the l-hook was not coded at the back and is heating up easily. Due to this issue, the doctor believes he's slightly burning the liver while doing the surgery. No surgery delay was reported as the device was replaced immediately. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00035 |
| MDR Report Key | 7344967 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-16 |
| Date of Report | 2018-02-19 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-02-19 |
| Date Added to Maude | 2018-03-16 |
| 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 | L-SHAPE HOOK ELECTRODE 5MM32CM |
| Generic Name | ELECTROSURGICAL COAGULATION |
| Product Code | KNF |
| Date Received | 2018-03-16 |
| Catalog Number | 600318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-03-16 |