MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-09-28 for OLYMPUS A5393 NA manufactured by Olympus Winter & Ibe Gmbh.
[18949497]
A hospital physician reported that the insulation attached to a bipolar forceps was peeling off the sides of the instrument and the gray plastic trocar tube (not an olympus product) had a chunk of plastic missing from one edge. There were no reports of pieces falling into the patient and the procedure was completed without complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2001-00035 |
| MDR Report Key | 354240 |
| Report Source | 07 |
| Date Received | 2001-09-28 |
| Date of Report | 2001-08-27 |
| Date Mfgr Received | 2001-08-26 |
| Date Added to Maude | 2001-10-04 |
| 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 | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2 CORPORATE CENTER DRIVE |
| 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 |
| Brand Name | OLYMPUS |
| Generic Name | BIPOLAR FORCEPS |
| Product Code | HFB |
| Date Received | 2001-09-28 |
| Returned To Mfg | 2001-08-30 |
| Model Number | A5393 |
| Catalog Number | NA |
| Lot Number | 71W |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 343460 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM 22045 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | BIPOLAR FORCEPS |
| Baseline Model No | A5393 |
| 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 | K955649 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-09-28 |