MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-20 for MONOPOLAR CABLE 10 FEET 600290 manufactured by Integra York, Pa Inc..
[80793757]
On 7/12/17 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - a monopolar cable was returned in used condition, not showing any unusual markings. During the visual inspection of the cable it is noticed that the cable is cut and there is not visible arcing. Device history evaluation - dhr review. 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: hhe-926 issued 11/2/2010 for cable damage leading to a safety hazard is identified in risk management files as a potential source of fire and user / patient harm. Conclusion: the complaint report cannot be confirmed at this time due to the breakage of the cable, testing cannot be performed.
Patient Sequence No: 1, Text Type: N, H10
[80793758]
Customer initially reports that the monopolar cord started sparking then smoking during a surgical procedure. The staff cut it to stop the current to the field. There was no harm to the patient and they were delayed less than 5 minutes to retrieve a new monopolar cord. On (b)(6) 2017 customer confirms no harm done and no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00072 |
| MDR Report Key | 6728948 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-20 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-06-19 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-20 |
| 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 | 2017-07-20 |
| Returned To Mfg | 2017-07-05 |
| Catalog Number | 600290 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-07-20 |