MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, AIM COUPLER, 18MM, C-MOUNT; CONFOCAL OPTICAL IMAGING

Catalog Number	1588020122
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
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 the image was blurry during a procedure.
Event or Problem Description
It was reported that the image was blurry during a procedure.
Additional Manufacturer Narrative
Alleged failure: the account has found water inside the cameras and couplers.Most of these occurrences were identified in mdrd or prior to a procedure.There were 3 instances that the moisture inside the camera and coupler were noticed during a procedure (did not track specific serial numbers of these 3 units).All procedures were completed successfully.There was a minor delay to procedure (5 minutes max) to bring in a replacement camera head.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 problem quoted by the customer when we were not able to replicate it at our facility.Provable root causes could be moisture between camera head and coupler, or that the units were not cleaned properly.Squeaky endoclamp is a cosmetic issue due to the sterilization process.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, AIM COUPLER, 18MM, C-MOUNT
• Common Device Name: CONFOCAL OPTICAL IMAGING
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8756100
• Report Number: 0002936485-2019-00273
• Device Sequence Number: 19204648
• Product Code: OWN
• UDI-Device Identifier: 07613327174359
• UDI-Public: 07613327174359
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142310
• 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): 10/03/2019

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: 1588020122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1