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 Code Available (3191)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that quality of the picture deteriorated and led to conversion to an open procedure.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Please note that per additional information received, the issue was caused by the fluid management system, which is not owned by stryker.There is no alleged deficiency with the coupler.Alleged failure: the quality of the picture deteriorated.Probable root cause: - cables - connectors - digital board - main board - transition board - scope - light source - camera head - coupler - connected monitors - use error - manufacturing/ service nonconformity.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that quality of the picture deteriorated and led to conversion to an open procedure.

• 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: 8759042
• Report Number: 0002936485-2019-00278
• Device Sequence Number: 2523349
• Product Code: OWN
• UDI-Device Identifier: 07613327174359
• UDI-Public: 07613327174359
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1588020122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other