MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-04-28 for HYSTEROSCOPIC HOOK SCISSORS 8642.681 manufactured by Richard Wolf Gmbh.
[192257]
A hook scissors being used for hysteroscopy broke and some small metal piece of the jaw came off in the uterus. It is believed the pieces were irrigated out at the completion of the case. No metal fragments were recovered from the irrigant. There were no pt problems reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2000-00023 |
| MDR Report Key | 275929 |
| Report Source | 05 |
| Date Received | 2000-04-28 |
| Date of Report | 2000-03-29 |
| Date of Event | 2000-03-28 |
| Date Facility Aware | 2000-03-28 |
| Report Date | 2000-03-29 |
| Date Reported to Mfgr | 2000-03-29 |
| Date Mfgr Received | 2000-03-29 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2000-05-03 |
| 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 | 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 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYSTEROSCOPIC HOOK SCISSORS |
| Generic Name | HYSTEROSCOPIC HOOK SCISSORS |
| Product Code | HRR |
| Date Received | 2000-04-28 |
| Model Number | 8642.681 |
| Catalog Number | 8642.681 |
| Lot Number | P665320 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267076 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER 32 STR. KNITTLINGEN GM D 75438 |
| Baseline Brand Name | HYSTEROSCOPIC HOOK SCISSORS |
| Baseline Generic Name | HYSTEROSCOPIC HOOK SCISSORS |
| Baseline Model No | 8642.681 |
| Baseline Catalog No | 8642.681 |
| Baseline ID | P 665320 |
| Baseline Device Family | HOOK SCISSORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-04-28 |