MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-12-07 for ROTO-LOK HUNTER GRASPER 3.5 X 24 630164 manufactured by .
[1780601]
The customer reports the jaw broke during a laparoscopic cholecystectomy while grasping a hard gallbladder. It appeared to the customer that no parts were detached. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
[8945099]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2010-00018 |
| MDR Report Key | 1950091 |
| Report Source | 08 |
| Date Received | 2010-12-07 |
| Date of Report | 2010-12-07 |
| Date Mfgr Received | 2010-11-10 |
| Date Added to Maude | 2011-04-13 |
| 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 |
| Manufacturer Street | 311 ENTERPRISE DR. |
| 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 | ROTO-LOK HUNTER GRASPER 3.5 X 24 |
| Generic Name | NONE |
| Product Code | EXX |
| Date Received | 2010-12-07 |
| Catalog Number | 630164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-07 |