MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-26 for INFRAVISION IR ILLUMINATOR 0220180521 manufactured by Stryker Endoscopy-san Jose.
[4938596]
It was reported that the unit sparked when plugged in.
Patient Sequence No: 1, Text Type: D, B5
[12205260]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[29876909]
The product was returned for investigation and the reported failure mode was confirmed. The following was observed: the unit was due for calibration. This does confirm the alleged failure mode of sparking probable root cause: console ground failure. Current leakage too high. The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence.???????
Patient Sequence No: 1, Text Type: N, H10
[29876910]
It was reported that the unit sparked when plugged in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2014-00758 |
| MDR Report Key | 4123305 |
| Report Source | 06 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-02 |
| Date of Event | 2014-09-02 |
| Date Mfgr Received | 2014-09-02 |
| Date Added to Maude | 2014-10-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS SHAFER |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFRAVISION IR ILLUMINATOR |
| Generic Name | CARRIER, SPONGE, ENDOSCOPIC |
| Product Code | FGS |
| Date Received | 2014-09-26 |
| Returned To Mfg | 2014-09-02 |
| Catalog Number | 0220180521 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-26 |