MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2010-10-28 for WAVE SIDE GRASPER FORCEPS 8383.2937 manufactured by Richard Wolf Medical Instruments.
[1666024]
It was reported that during a surgical procedure a small hole was made in the transverse mesocolon just to the left of ligament of treitz. The small bowel was then delivered through this and up into the lesser sac. At this point, the proximal gastric pouch was grasped and elevated. A small gastrotomy was made in the lateral portion of the stomach. A stapler was chosen and utilized at this time. The anvil and trocar were placed into the abdomen. This was placed through the opening in the stomach pouch and exited from the mid portion of the pouch. This was closed using a stapler. While trying to remove the trocar or the anvil, the grasper instrument had one of its sides fracture. The piece was removed intact. There was no injury to the patient. There did not appear to be any retained pieces. The removed piece did fit nicely in with the instrument where it broke off.
Patient Sequence No: 1, Text Type: D, B5
[8895531]
Results: other service organization has repaired this device. Evaluation summary: visual inspection of the forceps with broken jaw showed no corrosion at the point of breakage. The broken jaw was returned with the forceps. There was no evidence of corrosion on the jaw. The forceps are approximately (b)(6). There is a date etched on the handle 1/10 r that indicates a repair by a repair service other than richard wolf medical instruments. Our service records for this facility did not show any repairs done with this lot number 1a07. Follow-up with the facility contact person did indicate that sometimes the surgeon will torque the forceps. The manufacturer will be investigating the forceps and a follow-up will be done should new developments occur. Cause of event: no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2010-00019 |
| MDR Report Key | 1888660 |
| Report Source | 00,06 |
| Date Received | 2010-10-28 |
| Date of Report | 2010-10-28 |
| Date of Event | 2010-09-23 |
| Date Mfgr Received | 2010-10-04 |
| Date Added to Maude | 2012-01-13 |
| 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 | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | ENDOPLUS |
| Manufacturer Street | 431 LEXINGTON DRIVE |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVE SIDE GRASPER FORCEPS |
| Generic Name | WAVE SIDE GRASPER FORCEPS |
| Product Code | BWB |
| Date Received | 2010-10-28 |
| Returned To Mfg | 2010-10-05 |
| Model Number | 8383.2937 |
| Catalog Number | 8383.2937 |
| Lot Number | 1A07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-28 |