MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-07 for ORIGIN * OMS-T10SB manufactured by Origin Medsystems, Inc..
[71612]
The end of the plastic lock on trocar seal broke off compromising the seal and causing a leak of co2. In order to complete the operative procedure, the laparoscopic birch procedure was converted to an open method procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 112327 |
| MDR Report Key | 112327 |
| Date Received | 1997-08-07 |
| Date of Report | 1997-08-06 |
| Date of Event | 1997-02-04 |
| Date Facility Aware | 1997-02-04 |
| Report Date | 1997-08-06 |
| Date Reported to Mfgr | 1997-08-07 |
| Date Added to Maude | 1997-08-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | ORIGIN |
| Generic Name | STRUCTURAL BALLOON TROCAR & INFLATION BULB 10 MM |
| Product Code | FCY |
| Date Received | 1997-08-07 |
| Returned To Mfg | 1997-02-04 |
| Model Number | * |
| Catalog Number | OMS-T10SB |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 110276 |
| Manufacturer | ORIGIN MEDSYSTEMS, INC. |
| Manufacturer Address | 135 CONSTITUTION DR. MENLO PARK CA 94028 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-08-07 |