MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-12-27 for FORCEPS, INSERT, PLATE SHAPED 8393.182 manufactured by Richard Wolf Gmbh.
[4047308]
Sales representative reported to richard wolf medical instruments corporation (rwmic) a patient returned to hospital after a bariatric procedure and is currently in for a prolonged stay. There were many instruments used during the procedure. Two have ben identified as being manufactured by richard wolf medical instruments corporation (b)(4). Forceps insert (8393. 182) (b)(4). Insulated sheath (8393. 913) (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11467008]
An investigation was completed as the actual device was returned to the rwmic facility on (b)(6) 2013. Segment connecting pullrod with jaw was broken. In addition, bottom half of wall surrounding the pin was missing. Teeth show signs of heavy use. When forceps assembled with sheath, all parts are contained. Device history: manufactured 05/2011, sold on (b)(4) 2012; no record of any repairs or routine maintenance of device. No similar complaints in the last five years. Labeling was reviewed and found to be adequate. I. E. Intended use, indications and field of use, preparation and cautions. Richard wolf considers this matter closed. However, in the event we receive additional info, we will provide fda with follow-up info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2013-00036 |
| MDR Report Key | 3554805 |
| Report Source | 07 |
| Date Received | 2013-12-27 |
| Date of Report | 2013-12-17 |
| Date of Event | 2013-12-01 |
| Date Facility Aware | 2013-12-17 |
| Report Date | 2013-12-27 |
| Date Reported to FDA | 2013-12-27 |
| Date Reported to Mfgr | 2013-12-27 |
| Date Added to Maude | 2014-01-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAWN CLARK |
| Manufacturer Street | PFORZHEIMER STRASSE 32 |
| Manufacturer City | KNITTLINGEN 75438 |
| Manufacturer Postal | 75438 |
| Manufacturer Phone | 9558016 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS, INSERT, PLATE SHAPED |
| Generic Name | FORCEPS INSERT |
| Product Code | FFF |
| Date Received | 2013-12-27 |
| Model Number | 8393.182 |
| Catalog Number | 8393.182 |
| Lot Number | 1130672 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STRASSE 32 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-12-27 |