MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1488010001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was a loss of visualization and surgical delay greater than 30 minutes.
Event or Problem Description
It was reported that there was a loss of visualization 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 communication log), and indicates: repair details: reported defect: (b)(4).The customer reported visual issues when the 1488 ccu and camera were in use during a cardiac case.The customer reported changes in ratio of screen, plus issues with aspect and colour.There was also intermittent recognition of the camera with the test screen appearing during use.Another stack was used to complete the case.There was a prolongation of surgery of 60 minutes, resulting from difficulties relating to the visual disturbance (as opposed to swapping out the stack) the camera had functioned as expected during set up.This was the first time the devices had been used during a case.Action taken: inspected internal components/ connections.Tests: function test.General inspection.Soak test.Pressure seal test - camera head electrical safety test - est107912.Passed all tests.Unable to duplicate reported defect, no faults found.Probable root cause: - cables - connectors - digital board - main board - transition board - fiber board - intermittence between transition board and ch connector - software - camera head - coupler - connected monitors - use error - manufacturing/ service nonconformity.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8888454
• Report Number: 0002936485-2019-00342
• Device Sequence Number: 16208168
• Product Code: GCJ
• UDI-Device Identifier: 07613327061017
• UDI-Public: 07613327061017
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K132785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 1488010001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1