MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for VITAL KNAPP IRIS SCISSORS CVD SHARP/SHRP OP5525 manufactured by Carefusion, Inc.
[130628861]
(b)(4). Report source. Site contact would be (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[130628862]
Customer reported that an iris scissor broke during a repair of the left temple and forehead with bilateral rotation flaps. It had a tip missing when it was removed from the patient. An x-ray was performed and nothing was identified still inside of the patient. The x-ray was negative. The tip was never found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01873 |
| MDR Report Key | 8166195 |
| Date Received | 2018-12-14 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-16 |
| Date Added to Maude | 2018-12-14 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITAL KNAPP IRIS SCISSORS CVD SHARP/SHRP |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT |
| Product Code | HNF |
| Date Received | 2018-12-14 |
| Catalog Number | OP5525 |
| Lot Number | XMRX08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-14 |