MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-24 for PKG, L11 LED LIGHT SOURCE WITH AIM 0220230300 manufactured by Stryker Endoscopy-san Jose.
[169071917]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[169071918]
It was reported the device shut off during a procedure, resulting in loss of image.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2019-00421 |
| MDR Report Key | 9110257 |
| Date Received | 2019-09-24 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-09-04 |
| Date Mfgr Received | 2019-09-04 |
| Device Manufacturer Date | 2019-07-25 |
| Date Added to Maude | 2019-09-24 |
| 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, L11 LED LIGHT SOURCE WITH AIM |
| Generic Name | CONFOCAL OPTICAL IMAGING |
| Product Code | OWN |
| Date Received | 2019-09-24 |
| Catalog Number | 0220230300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-09-24 |