MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-07-07 for A4695 NA manufactured by Olympus Winter & Ibe Gmbh.
[15675935]
A hosp nurse reported that the jaws of the grasping forceps broke off in the pt's uterus during a hysteroscopy procedure as a physician attempted to retrieve an intrauterine device. According to the nurse, half of the jaws were retrieved, but the second piece could not be located and therefore remained inside the pt's uterus. The nurse stated that the physician was not concerned about the missing piece since he felt that there was no place for the piece to migrate. The procedure was not completed because the intrauterine device was so deeply embedded into the uterus. Hospitalization was not required nor were antibiotics prescribed as a result of the occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2000-00025 |
| MDR Report Key | 285435 |
| Report Source | 06 |
| Date Received | 2000-07-07 |
| Date of Report | 2000-06-10 |
| Date of Event | 2000-06-02 |
| Date Mfgr Received | 2000-06-10 |
| Date Added to Maude | 2000-07-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2 CORPORATE CENTER DR |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6318445688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SEMI RIGHT FOREIGN BODY FORCEPS |
| Product Code | HCZ |
| Date Received | 2000-07-07 |
| Model Number | A4695 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 276222 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM 22045 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | SEMI RIGID FOREIGN BODY FORCEPS |
| Baseline Model No | A4695 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K790071 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-07-07 |