MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-10-05 for STRYKEFLOW2 PUMP & HANDPIECE WITH 10 FT OF TUBING * 0250070500 manufactured by Stryker Endoscopy Puerto Rico.
[19958717]
It was reported that the device leaks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648666-2005-00061 |
| MDR Report Key | 643927 |
| Report Source | 06 |
| Date Received | 2005-10-05 |
| Date of Report | 2005-09-06 |
| Date of Event | 2005-08-19 |
| Date Mfgr Received | 2005-09-06 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2005-11-02 |
| 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 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 | STRYKEFLOW2 PUMP & HANDPIECE WITH 10 FT OF TUBING |
| Generic Name | SUCTION/IRRIGATION SYSTEM |
| Product Code | EFS |
| Date Received | 2005-10-05 |
| Returned To Mfg | 2005-09-09 |
| Model Number | * |
| Catalog Number | 0250070500 |
| Lot Number | 05174FG2 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 633424 |
| Manufacturer | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Address | * ARROYO PR 00615 US |
| Baseline Brand Name | STRYKEFLOW2 PUMP & HANDPIECE WITH 10 FT OF TUBING |
| Baseline Generic Name | SUCTION/IRRIGATION SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 0250070500 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-05 |