MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-27 for L-SHAPE HOOK ELECTRODE 5MM32CM 600318 manufactured by Integra York, Pa Inc..
[115376699]
The device was not returned to the manufacturer for analysis. Investigation was based on pictures provided by the customer. The pictures showed that the tip of the instrument was not attached to the shaft. The complaint report of damaged tip 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
[115376700]
An operating room (or) inventory control lead reported that on (b)(6) 2018, as the item was being sterilized, the gold tip of the 600318 l-shape hook electrode was "blown out". Additional information was received from the customer on 17jul2018 indicating that by blown out it, the customer meant that the gold threaded pin was completely out of the tip and it was floating free with a "bunch" of black particles from the inside. The product was not in contact with the patient. The patient was prepped for surgery. There was no patient injury or death alleged. It was unknown if there was any surgery delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00099 |
| MDR Report Key | 7729216 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-07-06 |
| Date Mfgr Received | 2018-07-06 |
| Date Added to Maude | 2018-07-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-07-27 |
| Catalog Number | 600318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-07-27 |