MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for STRYKER DISPOSABLE SUCTION IRRIGATOR 250-070-520 manufactured by Stryker Endoscopy.
[92314864]
Laparoscopic suction irrigator had saline leaking out of the battery pack. The malfunctioning equipment did not reach the patient. There was no delay in care. The equipment was taken out of service and a new one was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073360 |
| MDR Report Key | 7037457 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-11-13 |
| Date Added to Maude | 2017-11-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKER DISPOSABLE SUCTION IRRIGATOR |
| Generic Name | DISPOSABLE SUCTION/IRRIGATOR |
| Product Code | LJH |
| Date Received | 2017-11-15 |
| Catalog Number | 250-070-520 |
| Lot Number | 17299FG2 |
| Device Expiration Date | 2019-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-15 |