MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-07-28 for STRYKEFLOW2 WITHOUT TIP (6BX) * 0250070500 manufactured by Stryker Endoscopy Puerto Rico.
[19165266]
The strykeflow suction irrigation device was leaking brown fluid from the battery pack - some of this fluid splashed onto the rn's clothes, which started to irritate her skin. The device was removed from the procedure and one of the nurses opened the battery pack and the batteries inside appeared corroded. No harm was done to the pt.
Patient Sequence No: 1, Text Type: D, B5
[19330823]
Device is currently being shipped overseas and has not reached our site for investigation. When rec'd, a f/u report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2006-00034 |
| MDR Report Key | 753613 |
| Report Source | 01,06 |
| Date Received | 2006-07-28 |
| Date of Report | 2006-07-02 |
| Date of Event | 2006-07-01 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2006-08-24 |
| 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 PUERTO RICO |
| Manufacturer Street | LAS PALMAS INDUSTRIAL PARK HWY #3 KM 130.2 |
| Manufacturer City | ARROYO 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 | STRYKEFLOW2 WITHOUT TIP (6BX) |
| Generic Name | SUCTION/IRRIGATION DEVICE |
| Product Code | EFS |
| Date Received | 2006-07-28 |
| Model Number | * |
| Catalog Number | 0250070500 |
| Lot Number | 06052FG2 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | MO |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 741421 |
| Manufacturer | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Address | * ARROYO PR 00615 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-28 |