MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-23 for OLYMPUS TRIPORT WA58010T manufactured by Olympus America Inc.
[21540247]
Surgical procedures for bilateral salpingo-oophorectomy. Olympus triport ref was5802ot lot 108791 was used. Surgeon states co2 starting leaking after first ovary and fallopian tube was dissected. Abdomen delated per surgeon and he requested the second triport. Per surgeon, the second triport leaked co2. Surgeon used a third triport, which did not leak. The surgeon thought an ovary was still in the pt's abdomen. The surgeon searched and then found the ovary in the first triport used. Surgeon explained the ovary must have been sucked up in the triport when the co2 was lost due to malfunction of the triport.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4758433 |
| MDR Report Key | 4758433 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-12 |
| Date Facility Aware | 2015-01-12 |
| Report Date | 2015-01-19 |
| Date Added to Maude | 2015-05-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS TRIPORT |
| Generic Name | OLYMPUS TRIPORT |
| Product Code | OKX |
| Date Received | 2015-04-23 |
| Model Number | WA58010T |
| Catalog Number | WA58010T |
| Lot Number | 108791 |
| Device Expiration Date | 2019-07-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA INC |
| Manufacturer Address | 3500 CORPORATE PKWY PO BOX 610 CENTER VALLEY PA 18034061 US 18034 0610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-23 |