MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-20 for MONOPOLAR CABLE 10 FEET 600290 manufactured by Integra York, Pa Inc..
[92509209]
(b)(6) integra investigation completed. Failure analysis, device history evaluation. Failure analysis - complaint is unconfirmed; this is due to the product not being returned for review. Complaint will be reopened if product is received. Device history evaluation - device history reviewed and there were no anomalies found for reported incident. 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
[92509210]
Customer initially reports the item is sparking and blowing the cord apart where it plugs into the generator. On (b)(6) customer reports laparoscopic robot assisted low anterior colon resection in progress, patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00138 |
| MDR Report Key | 7045193 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-20 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-10-27 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2017-11-20 |
| 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 | 2017-11-20 |
| 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 | 2017-11-20 |