MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-05-25 for STRYKER SUCTION IRRIGATOR II 0250-070-500 NA manufactured by Stryker Endoscopy ..
[377692]
It was reported that when using the suction, a portion of the bowel came in contact with the suction tip. An additional entry port was necessary to release the bowel from the suction tip. No adverse effectto the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648666-2004-00032 |
| MDR Report Key | 585897 |
| Report Source | 07 |
| Date Received | 2004-05-25 |
| Date of Report | 2004-05-18 |
| Date of Event | 2004-04-08 |
| Date Mfgr Received | 2004-05-18 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2005-03-30 |
| 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 Street | 5900 OPTICAL CT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER SUCTION IRRIGATOR II |
| Generic Name | SUCTION IRRIGATOR |
| Product Code | EFS |
| Date Received | 2004-05-25 |
| Model Number | 0250-070-500 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 575729 |
| Manufacturer | STRYKER ENDOSCOPY . |
| Manufacturer Address | 5900 OPTICAL CT SAN JOSE CA 95138 US |
| Baseline Brand Name | STRYKEFLOW SUCTION IRRIGATOR II |
| Baseline Generic Name | SUCTION IRRIGATOR |
| Baseline Model No | 0250-070-500 |
| Baseline Catalog No | N/ |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-25 |