MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-03-03 for HULKA TENACULUM FORCEP 8371.00 manufactured by Richard Wolf Gmbh.
[17513145]
A diagnostic laparoscopy procedure was in progress when the tenaculum forcep, for manipulating the uterus, broke. The curved jaw section, measuring approximately 135mm in length, had broken off and remained inserted in the uterus. The metal piece was removed, with no injury to the pt being observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2001-00025 |
| MDR Report Key | 323878 |
| Report Source | 00 |
| Date Received | 2001-03-03 |
| Date of Report | 2001-03-02 |
| Date of Event | 2001-02-23 |
| Date Facility Aware | 2001-02-23 |
| Report Date | 2001-03-02 |
| Date Reported to Mfgr | 2001-03-02 |
| Date Mfgr Received | 2001-03-02 |
| Device Manufacturer Date | 1987-09-01 |
| Date Added to Maude | 2001-04-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JERRY BALOK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HULKA TENACULUM FORCEP |
| Generic Name | UTERINE TENACULUM FORCEP |
| Product Code | HDC |
| Date Received | 2001-03-03 |
| Model Number | 8371.00 |
| Catalog Number | 8371.00 |
| Lot Number | A-I-L |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 13 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 313353 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | HULKA TENACULUM FORCEP |
| Baseline Generic Name | UTERINE TENACULUM FORCEP |
| Baseline Model No | 8371.00 |
| Baseline Catalog No | 8371.00 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-03-03 |