MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-12 for STRYKER 210-114-100 manufactured by Stryker Instruments.
[1061872]
Battery leak observed during surgery. A pulse lavage irrigator was in use when the o. R. Nurse noticed a weak stream of irrigant. The o. R. Nurse inspected the device more closely and saw the corrosive substance at juncture of the battery pack. Some residue also seen on tubing. The pulse lavage irrigator was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010306 |
| MDR Report Key | 1343948 |
| Date Received | 2009-03-12 |
| Date of Report | 2009-03-12 |
| Date of Event | 2009-03-03 |
| Date Added to Maude | 2009-03-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER |
| Generic Name | PULSE LAVAGE IRRIGATOR |
| Product Code | KQT |
| Date Received | 2009-03-12 |
| Model Number | 210-114-100 |
| Catalog Number | 210-114-100 |
| ID Number | NA |
| Device Expiration Date | 2011-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-12 |