MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, VISIONPRO SYNK 26" WIRELESS LED DISPLAY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0240031000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the monitor fell.The nurse needed no treatment and the procedure was completed successfully.
Additional Manufacturer Narrative
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: monitor fell and hit the nurse not sure if it was installed incorrectly or if something else caused it the nurse was hit but not sure how bad the nurse is hurt at this time the failure identified in the investigation is consistent with the complaint record.The probable root cause could be the screws were not tightened, improper installation or the monitor go dropped during transport.Manufacture date is not known.
Event or Problem Description
It was reported that the monitor fell.The nurse needed no treatment and the procedure was completed successfully.

• Brand Name: PKG, VISIONPRO SYNK 26" WIRELESS LED DISPLAY
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7674290
• Report Number: 0002936485-2018-00529
• Device Sequence Number: 19044665
• Product Code: GCJ
• UDI-Device Identifier: 07613327056068
• UDI-Public: 07613327056068
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K081995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0240031000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1