VISIONPRO SYNK 26" WIRELESS LED DISPLAY INTERNATIONAL KIT
Report
- Report Number
- 0002936485-2023-01203
- Event Type
- Malfunction
- Date Received
- November 28, 2023
- Date of Event
- November 3, 2023
- Report Date
- July 12, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- PMA / PMN Number
- K081995
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
PRODUCT WAS RECEIVED IN-HOUSE AT STRYKER ENDOSCOPY AND INADVERTENTLY SHIPPED TO OEM- BARCO. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE ALLEGED FAILURE: DISPLAY/ DISPLAY POWER SUPPLY TOO HEAVY PROBABLE ROOT CAUSE: MOUNTING MECHANISM BREAKS (FOR EX: (BOOM ARM / VIDEO CART MOUNT ETC). USE ERROR . THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
IT WAS REPORTED THAT THE MONITOR FELL AND HIT A STAFF MEMBER. PLEASE NOTE THAT THE STAFF MEMBER WAS NOT INJURED AND NO MEDICAL TREATMENT WAS REQUIRED.
IT WAS REPORTED THAT THE MONITOR FELL AND HIT A STAFF MEMBER. PLEASE NOTE THAT THE STAFF MEMBER WAS NOT INJURED AND NO MEDICAL TREATMENT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 512067 | VISIONPRO SYNK 26" WIRELESS LED DISPLAY INTERNATIONAL KIT | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |