MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, VISIONPRO 26" LED DISPLAY; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO

Model Number	0240031020
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that there was loss of visualization during procedure, causing gallbladder injury and surgical delay greater than 30 minutes.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached (see comm log), and indicates: intermittent failure of endo devices on laparoscopy towers.Devices switch themselves off and on again the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was loss of visualization during procedure, causing gallbladder injury and surgical delay greater than 30 minutes.

• Brand Name: PKG, VISIONPRO 26" LED DISPLAY
• Common Device Name: CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9850483
• Report Number: 0002936485-2020-00132
• Device Sequence Number: 19557235
• Product Code: FWB
• UDI-Device Identifier: 07613327056082
• UDI-Public: 07613327056082
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0240031020
• Device Catalogue Number: 0240031020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR