MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-22 for PKG, L10 LED LIGHT SOURCE WITH AIM 0220220300 manufactured by Stryker Endoscopy-san Jose.
[155331005]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[155331006]
It was reported that the stent did not fully light up. Please note, once the connectors were switched, both stents lit up, and the procedure was completed successfully using the same devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2019-00356 |
| MDR Report Key | 8923630 |
| Date Received | 2019-08-22 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-07-29 |
| Date Mfgr Received | 2019-07-29 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2019-08-22 |
| 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 | 3 |
| Manufacturer Contact | MR. MICHELLE TO |
| 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 | 0 |
| Brand Name | PKG, L10 LED LIGHT SOURCE WITH AIM |
| Generic Name | CONFOCAL OPTICAL IMAGING |
| Product Code | OWN |
| Date Received | 2019-08-22 |
| Returned To Mfg | 2019-08-15 |
| Catalog Number | 0220220300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-08-22 |