MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-26 for HIGH FLOW HEATED INSUFFLATOR-TUBING REF 620-030-407 manufactured by Stryker Endoscopy.
[2477783]
During removal of the suction irrigator, dark brown gritty fluid was noted to be leaking from the battery component. Apparently the irrigation fluid was suctioned into the battery compartment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2480685 |
| MDR Report Key | 2480685 |
| Date Received | 2012-02-26 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-01-11 |
| Report Date | 2012-02-24 |
| Date Reported to FDA | 2012-02-26 |
| Date Added to Maude | 2012-03-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH FLOW HEATED INSUFFLATOR-TUBING |
| Generic Name | HIGH FLOW HEATED INSUFFLATOR-TUBING |
| Product Code | NKC |
| Date Received | 2012-02-26 |
| Returned To Mfg | 2012-01-27 |
| Model Number | NA |
| Catalog Number | REF 620-030-407 |
| Lot Number | 11257FE2; 2014-09 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-26 |