MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-10-18 for STRYKERFLOW2 WITHOUT TIP (6BX) * 0250070500 manufactured by Stryker Endoscopy Puerto Rico.
[18223816]
It was reported that the product was connected to a bag with normal saline. When the surgeon pushed the button for irrigation, the normal saline splashed all over from the bottom of the battery part. Another new one was used without problem. There was no injury or intervention required due to the event.
Patient Sequence No: 1, Text Type: D, B5
[18385640]
Device was received at our distribution location and sent to the mfg site for evaluation. Once complete, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2006-00046 |
| MDR Report Key | 910945 |
| Report Source | 01,06 |
| Date Received | 2006-10-18 |
| Date of Report | 2006-09-21 |
| Date of Event | 2006-09-19 |
| Date Mfgr Received | 2006-09-21 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2007-09-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | BETH ONDERLINDE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY |
| Manufacturer Street | HIGHWAY #3 KM 130.2 |
| Manufacturer City | ARROVO PR 00615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKERFLOW2 WITHOUT TIP (6BX) |
| Generic Name | SUCTION/IRRIGATION DEVICE |
| Product Code | EFS |
| Date Received | 2006-10-18 |
| Returned To Mfg | 2006-10-06 |
| Model Number | * |
| Catalog Number | 0250070500 |
| Lot Number | 06230FG2 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 884579 |
| Manufacturer | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Address | * ARROYO PR 00615 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-18 |