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

Catalog Number	1488010000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
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 image.The procedure was completed successfully.
Additional Manufacturer Narrative
Based off of previous complaint investigation (b)(4), the failure alleged in the complaint record was not confirmed during the product investigation.Alleged failure: ccu does not give image on sdc or go direct to the sdc.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: it is difficult to determine the root cause of the issue observed at the account since we are unable to replicate the problem in-house.Most provable root cause could be the sdc or cables related issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a loss of image.The procedure was completed successfully.

• Brand Name: PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8888444
• Report Number: 0002936485-2019-00339
• Device Sequence Number: 16497143
• Product Code: GCJ
• UDI-Device Identifier: 07613327061024
• UDI-Public: 07613327061024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132785
• 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): 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: 1488010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• 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