MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-19 for SPATULA ELECTRODE 5MM 32CM 600317 manufactured by Integra York, Pa Inc..
[128284727]
The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[128284728]
Sus voluntary event report foi for manufacturers (mw5080279) was received on 29oct2018 with the following information. On (b)(6) 2018, a spark occurred in an unspecified surgery while using the 600317 spatula electrode 5mm 32cm. Additional information was received on 30oct2018 and 02nov2018, stating that the patient was prepped for surgery, and there was no surgical delay. There was no patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00141 |
| MDR Report Key | 8086252 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-19 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2018-11-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SPATULA ELECTRODE 5MM 32CM |
| Generic Name | ELECTROSURGICAL COAGULATION |
| Product Code | KNF |
| Date Received | 2018-11-19 |
| Catalog Number | 600317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-19 |