MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-17 for STRYKER 100 COMMAND RECIPROCATING SAW UNKNOWN 229-637 manufactured by Stryker Instruments Div. Stryker Corp..
[19233927]
During use, reciprocating saw leaked black fluid into pt's oral cavity. Instrument was removed from field and sent to biomedical engineering for evaluation. Pt's oral cavity was irrigated with 1000 cc of saline. Procedure was completed. Pt was in stable condition. At post-op, no infection; no sequelae from incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29955 |
| MDR Report Key | 29955 |
| Date Received | 1996-01-17 |
| Date of Report | 1996-01-10 |
| Date of Event | 1995-11-29 |
| Report Date | 1996-01-10 |
| Date Added to Maude | 1996-02-13 |
| 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 | STRYKER 100 COMMAND RECIPROCATING SAW |
| Generic Name | DENTAL SAW |
| Product Code | DZH |
| Date Received | 1996-01-17 |
| Model Number | UNKNOWN |
| Catalog Number | 229-637 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31048 |
| Manufacturer | STRYKER INSTRUMENTS DIV. STRYKER CORP. |
| Manufacturer Address | 420 ALCOTT ST KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-01-17 |