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 2018-11-26 for ROTO-CAM MARYLAND DISS MONO 5 625126 manufactured by Integra York, Pa Inc..
[128405116]
The device was not yet 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
[128405117]
It was reported by a customer that on (b)(6) 2018, a 625126 roto-cam maryland dissector monopolar was found stained with color brown in the sterile pack after "vacuum cleaning" and sterilization. The product was not in contact with the patient. No patient injury or death alleged, and the event did not lead to increase the surgery time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00170 |
| MDR Report Key | 8103531 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2018-11-26 |
| 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 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 | ROTO-CAM MARYLAND DISS MONO 5 |
| Generic Name | DISSECTING FORCEPS AND HOOKS |
| Product Code | KNF |
| Date Received | 2018-11-26 |
| Returned To Mfg | 2018-12-05 |
| Catalog Number | 625126 |
| Lot Number | 100161-1412 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-11-26 |