MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-05 for STRYKEFLOW 0250070500 250-070-500 manufactured by Stryker Corporation.
[76628415]
Patient Sequence No: 1, Text Type: N, H10
[76628416]
The suction irrigator was attached to a 3000 ml bag of normal saline. It started leaking into the battery compartment. It was a fire hazard since the batteries were hot after removing it from the compartment. The actual saline bag was not leaking. However, it was noticed that the fluid from the bag was leaking into the battery compartment of suction irrigator so the suction irrigator was faulty. The bag itself had no holes and was okay. Suction irrigators are manufactured by stryker company. It is a one-time use (disposable) so clinical engineering was not notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6610471 |
| MDR Report Key | 6610471 |
| Date Received | 2017-06-05 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-05-24 |
| Report Date | 2017-06-01 |
| Date Reported to FDA | 2017-06-01 |
| Date Reported to Mfgr | 2017-06-01 |
| Date Added to Maude | 2017-06-05 |
| 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 | 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 | 3 |
| Brand Name | STRYKEFLOW |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | NLM |
| Date Received | 2017-06-05 |
| Model Number | 0250070500 |
| Catalog Number | 250-070-500 |
| Lot Number | 17059FG2 |
| ID Number | REF 250-070-500 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 5900 OPTICAL CT. SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-05 |