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 2018-02-21 for L-SHAPE HOOK ELECTRODE 5MM32CM 600318 manufactured by Integra York, Pa Inc..
[100781130]
The device has not been returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report number 2523190-2018-00018 and 2523190-2018-00019.
Patient Sequence No: 1, Text Type: N, H10
[100781231]
This is 3 of 3 reports: a customer reported to integra that a 600318 l-shape hook electrode was used during an unspecified procedure that the insulation was burning off at the end of the electrode prematurely exposing the metal which can cause burns. The device was in contact with the patient but no patient injury was reported. No surgery delay was reported due to product problem. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00020 |
| MDR Report Key | 7286880 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-21 |
| Date of Report | 2018-01-30 |
| Date Mfgr Received | 2018-02-22 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2018-02-21 |
| 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 | 2018-02-21 |
| Returned To Mfg | 2018-02-15 |
| Catalog Number | 600318 |
| 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 | 2018-02-21 |