MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-24 for FORCEPS, TENACULUM 8370.26 manufactured by Richard Wolf Medical Instruments Corp..
[4033923]
Facility reported during a case, after forceps were inserted into patient and opened, the instrument would not close. Doctor had to do a mini-laparotomy to remove device. Patient had a 3" incision instead of normal puncture hole. In order to remove tenaculum from patient, doctor performed a mini-laparotomy therefore patient had a 3" incision instead of the normal puncture hole. Customer also reported a delay in scheduled procedure as a result of the unscheduled mini-laparotomy.
Patient Sequence No: 1, Text Type: D, B5
[11540509]
Handle is manufactured by richard wolf. It is then sent to endoplus where they manufacture and attach the insulated sheath and forceps. Completed device is then returned to richard wolf for distribution. Investigation is currently open and being performed on the actual device. Richard wolf received device, performed a visual/functional evaluation and then sent device to endoplus facility on (b)(4) 2013 for further investigation. No damage was detected and device worked as intended at rwmic facility. Manufacture date: march 2013. Distribution date: may 2013. There have been no similar events in the last four years. Labeling was reviewed and found to be adequate, i. E. Intended use, indications and field of use, preparation and cautions. Rwmic considers this matter open and will provide fda with follow-up information when investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2013-00027 |
| MDR Report Key | 3589703 |
| Report Source | 06 |
| Date Received | 2013-10-24 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-09-01 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-02-28 |
| 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 | DAWN CLARK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | ENDOPLUS |
| Manufacturer Street | 431 LEXINGTON DRIVE SUITE A |
| Manufacturer City | BUFFALO GROVE IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS, TENACULUM |
| Generic Name | FORCEPS |
| Product Code | HCZ |
| Date Received | 2013-10-24 |
| Returned To Mfg | 2013-10-22 |
| Model Number | 8370.26 |
| Catalog Number | 8370.26 |
| Lot Number | 1M13 |
| 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 CORP. |
| Manufacturer Address | VERNON HILLS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-24 |