MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-11-24 for SARGIS UTERINE GRASPING FORCEPS 8370.00 manufactured by Richard Wolf Gmbh.
[17025627]
A vaginal hysterectomy procedure was being done when the uterine grasping forceps broke. The distal metal tip was in the uterus as the uterus was taken out. No pt consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1999-00051 |
| MDR Report Key | 251770 |
| Report Source | 05 |
| Date Received | 1999-11-24 |
| Date of Report | 1999-10-27 |
| Date of Event | 1999-10-26 |
| Date Facility Aware | 1999-10-26 |
| Report Date | 1999-10-27 |
| Date Reported to Mfgr | 1999-10-27 |
| Date Mfgr Received | 1999-10-27 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 1999-12-02 |
| 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 COPORATE WOODS PARKWAY |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARGIS UTERINE GRASPING FORCEPS |
| Generic Name | UTERINE GRASPING FORCEPS |
| Product Code | HCZ |
| Date Received | 1999-11-24 |
| Returned To Mfg | 1999-11-17 |
| Model Number | 8370.00 |
| Catalog Number | 8370.00 |
| Lot Number | P665309 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 243842 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | SARGIS UTERINE GRASPING FORCEPS |
| Baseline Generic Name | UTERINE GRASPING FORCEPS |
| Baseline Model No | 8370.00 |
| Baseline Catalog No | 8370.00 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-24 |