MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-06-22 for MONOPOLAR CABLE 10 FEET 600290 manufactured by Integra York, Pa Inc..
[78259020]
On 6/12/17 integra investigation completed. Method: failure analysis. Device history evaluation results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation. Unconfirmed/no return of device for evaluation. Device history evaluation - device nonconforming product report / nonconforming material report history: none variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none health hazard evaluation history: monopolar hhe gsop-926 was issued on 12/08/2010. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[78259021]
Incident 2 of 2 (first incident not identified). Fda ref #mw5069372 reports that the monopolar cautery cord was completely severed from where it was attached to the bovie machine and the rest of the cord was dangling on the floor from the patients sterile field. No sparks were seen according to the surgeon, assistant and surgical tech. The monopolar cautery was not currently in use when it occurred, the tech did mention, however, that he heard a pop and then the surgeon stated that something fell (which was the remainder of the cord). The cord along with the attachment was removed, inspected further, disinfected, and put aside in a bag. The cord was replaced with another that was pee-packed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00067 |
| MDR Report Key | 6660032 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-06-22 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-04-18 |
| Date Mfgr Received | 2017-05-30 |
| Date Added to Maude | 2017-06-22 |
| 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 SANDRA LEE |
| 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 | MONOPOLAR CABLE 10 FEET |
| Generic Name | ELECTROSURGICAL COAGULATION |
| Product Code | KNF |
| Date Received | 2017-06-22 |
| Catalog Number | 600290 |
| 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 | 2017-06-22 |