MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIM 4K COUPLER, 20MM, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1688020122
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a potential for adverse consequences due to blurry image.
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.
Additional Manufacturer Narrative
Alleged failure: device was blurry despite getting another scope and cleaning the camera head and coupler.Issue was noticed when camera was turned on and tried to focus.No full loss of image, same devices could not be used to complete procedure.Procedure completed successfully with 10-20 minute delay.No impact to patient.] the failure(s) identified in the investigation is consistent with the complaint record.Root cause: moisture in camera head due to a leak at the window.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was a potential for adverse consequences due to blurry image.

• Brand Name: AIM 4K COUPLER, 20MM, C-MOUNT
• 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: 13772994
• Report Number: 0002936485-2022-00121
• Device Sequence Number: 11906179
• Product Code: GCJ
• UDI-Device Identifier: 07613327382389
• UDI-Public: 07613327382389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 1688020122
• Device Catalogue Number: 1688020122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/11/2022
• 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