MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-05 for CRILE FCPS 6-1/4 CVD MIRROR 105141 manufactured by Integra York, Pa Inc..
[141495645]
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
[141495646]
Sus voluntary event report foi for manufacturers (mw5084508) received on 19mar2019 for product id 105141, crile fcps 6-1/4 cvd mirror with the following information: on (b)(6) 2019, a nurse reported that an approximately 5mm portion crile artery forceps (6 1/4) curved clamp tip (1 tip), was identified to be missing at the conclusion of an unspecified procedure. The device was in contact with the patient and no obvious, immediate injury was observed. It was reported that a surgical delay (several minutes) occurred to perform an intra-operative x-ray to identify any potentially retained metallic bodies and for removal of the broken portion of the instrument. No impact to the patient. The patient status after the procedure was stable and recovering from the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00053 |
| MDR Report Key | 8488004 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-04-05 |
| 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 |
| 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 | CRILE FCPS 6-1/4 CVD MIRROR |
| Generic Name | N/A |
| Product Code | HRQ |
| Date Received | 2019-04-05 |
| Returned To Mfg | 2019-04-09 |
| Catalog Number | 105141 |
| 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 | 2019-04-05 |