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

Model Number	1688020122
Medical Device Problem Codes	Fogging (1253); Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was an unclear image.
Event or Problem Description
It was reported that there was an unclear image.
Additional Manufacturer Narrative
Alleged failure: foggy image.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: no problem found.The coupler is in good condition and functions according to specifications.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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
• MDR Report Key: 10273932
• Report Number: 0002936485-2020-00274
• Device Sequence Number: 19546399
• Product Code: GCJ
• UDI-Device Identifier: 07613327382389
• UDI-Public: 07613327382389
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1