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

Model Number	1588020122
Medical Device Problem Codes	Poor Quality Image (1408); Product Quality Problem (1506)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
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 image loss for about five minutes.
Additional Manufacturer Narrative
Alleged failure: threads worn down on both sides, falls right out during use.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: worn out threads most likely caused by the customer not screwing the coupler to the camera head correctly.Coupler was previously repaired by a third party repair house.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 image loss for about five minutes.

• 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: 10336133
• Report Number: 0002936485-2020-00313
• Device Sequence Number: 14104159
• Product Code: OWN
• UDI-Device Identifier: 07613327174359
• UDI-Public: 07613327174359
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 09/16/2020

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: 1588020122
• Device Catalogue Number: 1588020122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1