MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-29 for STRYKER STRYKEFLOW II manufactured by Stryker.
[1809764]
Laparoscopic suction/irrigator would not operate as physician tried to use the first time. Operating room manager said this instrument comes ready to use, batteries included. Unk if it was a defect with the contact of the batteries or what. Manufacturer rep was notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018412 |
| MDR Report Key | 1916869 |
| Date Received | 2010-11-29 |
| Date of Report | 2010-11-29 |
| Date of Event | 2010-11-19 |
| Date Added to Maude | 2010-12-10 |
| 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 | 0 |
| 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 STRYKEFLOW II |
| Generic Name | LAPAROSCOPIC SUCTION/IRRIGATOR |
| Product Code | KQT |
| Date Received | 2010-11-29 |
| Lot Number | 10268FG2 |
| Device Expiration Date | 2012-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-29 |