MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-10-12 for OLYMPUS A4801A NA manufactured by Olympus Winter & Ibe Gmbh.
[200139]
An olympus sales rep reported intermittent loss of image during a laparoscopic cholecystectomy procedure. The procedure was completed with the same video laparoscope and there no injuries related to the occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2000-00036 |
| MDR Report Key | 300376 |
| Report Source | 07 |
| Date Received | 2000-10-12 |
| Date of Report | 2000-09-13 |
| Date Mfgr Received | 2000-09-13 |
| Date Added to Maude | 2000-10-18 |
| 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 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | VIDEO LAPAROSCOPE |
| Product Code | FEJ |
| Date Received | 2000-10-12 |
| Returned To Mfg | 2000-09-13 |
| Model Number | A4801A |
| Catalog Number | NA |
| Lot Number | NA |
| 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 | 290732 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM 22045 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | VIDEO LAPAROSCOPE |
| Baseline Model No | A4801A |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-10-12 |