MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-02-09 for FUNDUS GRASP FCP ROTO-LOK 45CM 625107D5 manufactured by J. Jamner Surgical Instruments.
[1332912]
The customer initially reports that the device broke during surgery. The director of surgical services reports via telephone that during a laparoscopic cholecystectomy when grasping a "tight" gallbladder (which made if difficult to grasp) extra pressure was applied to get a good bite, and the jaw snapped. The director reports that no piece broke off in the pt; therefore, the surgeon decided no x-ray was necessary. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[8488762]
The device involved in the reported incident has been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2010-00007 |
| MDR Report Key | 1626040 |
| Report Source | 06 |
| Date Received | 2010-02-09 |
| Date of Report | 2010-02-09 |
| Date Mfgr Received | 2009-12-02 |
| Date Added to Maude | 2011-02-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUNDUS GRASP FCP ROTO-LOK 45CM |
| Generic Name | GRASPING FORCEPS |
| Product Code | HDC |
| Date Received | 2010-02-09 |
| Catalog Number | 625107D5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. JAMNER SURGICAL INSTRUMENTS |
| Manufacturer Address | HAWTHORNE NY 10532 US 10532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-09 |