MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-01-24 for WAVE SIDE GRASPER FORCEPS 8383.2937 manufactured by Richard Wolf Medical Instruments Corporation.
[2561012]
Facility report: lap hernia repair performed by surgeon on (b)(6) 2011. During the case an instrument called a grasper was used. A portion of the instrument broke off during the procedure. The surgeon attempted to locate the broken grasper piece on the monitor. Fluoro was brought in and the grasper piece was identified but it could not be removed laparoscopically. Small incision was made and the piece of the grasper was recovered. E-mail received from the facility on (b)(4) 2011 reported that "the pt is doing well. "
Patient Sequence No: 1, Text Type: D, B5
[9590088]
Device was received and evaluated internally by richard wolf medical instruments corporation (rwmic) and manufacturing site (b)(4). Broken jaw was confirmed. Top jaw is still intact but is bent sideways indicating the instrument was misused. Distribution date: 12/2008. Facility has purchased 126 wave side graspers ytd, 21 devices were labeled with lot # 1m08. (b)(4). Service records were reviewed, facility has not used rwmic as their service provider for this device since distribution ((b)(4), all lot numbers). An e-mail received from this facility confirmed that they are using 3rd party services after warranty period. (b)(4). Rwmic has two mdr's on file that were a result of breakage during a lap hernia procedure (1418479-2011-00021 and 1418479-2011-00025). Lot number and facility are not the same. Based on info, likely root cause is misuse (not used as intended), excessive force (i. E. Pulling or twisting sideways), and improper maintenance (i. E. None or un-authorized repair).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2011-00025 |
| MDR Report Key | 2433540 |
| Report Source | 00,06 |
| Date Received | 2012-01-24 |
| Date of Report | 2012-01-24 |
| Date of Event | 2011-12-07 |
| Date Mfgr Received | 2011-12-08 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2012-02-03 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RON HASELHORST |
| Manufacturer Street | 353 CORPORATE WOODS PKWY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479131113 |
| 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 | 2012-01-24 |
| Returned To Mfg | 2011-12-22 |
| Model Number | 8383.2937 |
| Catalog Number | 8383.2937 |
| Lot Number | 1M08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
| Manufacturer Address | VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-01-24 |