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

Model Number	1488010001
Medical Device Problem Codes	No Display/Image (1183); Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a loss of image.
Event or Problem Description
It was reported that there was a loss of image.
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: "summary of evaluation: wear / damage to the channel 1 dvi connector, interference at the image replaced the digital board assembly, transition board assembly and ribbon cable updated software to latest version, completed qip.Device will be shipped back to the customer".The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: 1488 HD 3-CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER - INTERNATIONAL KIT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13544516
• Report Number: 0002936485-2022-00084
• Device Sequence Number: 11829989
• Product Code: GCJ
• UDI-Device Identifier: 07613327061017
• UDI-Public: 07613327061017
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/06/2022

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 Model Number: 1488010001
• Device Catalogue Number: 1488010001I
• Device Lot Number: 15K028024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown