MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-13 for MONOPOLAR CABLE 10 FEET 600290 manufactured by Integra York, Pa Inc..
[77496726]
On 6/12/2017 integra investigation completed. Method: failure analysis, device history evaluation: results: failure analysis - one monopolar cable returned in used condition, showing minimal wear. There is a break in the cord. It appears there might have been damage to this area prior to the fire, there is blue tape on the cord right where the fire began. This item is from an old design we no longer have this item in production. Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: there is no applicable variance authorization / deviation history. 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: for cable damage leading to safety hazards (fires, sparks, smoke). Conclusion : the complaint report of damage has been confirmed; the root cause of the damage has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[77496727]
Customer initially reports a patient related fire incident. Physician was operating with l-hook and grey cord. The grey cord started a fire during surgery. Cable split in half and burned through foam arm rest. Patient was unharmed. On (b)(6)17 customer reports event occurred during a laparoscopic cholecystectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00066 |
| MDR Report Key | 6638506 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-13 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-16 |
| Device Manufacturer Date | 2014-11-20 |
| Date Added to Maude | 2017-06-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2017-06-13 |
| Returned To Mfg | 2017-05-22 |
| Catalog Number | 600290 |
| Lot Number | 100197-1411 |
| 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 | 2017-06-13 |