MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM X 0°, 33CM; CONFOCAL OPTICAL IMAGING

Catalog Number	0502937010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported the image was blurry, a backup device was used to complete procedure.
Additional Manufacturer Narrative
Alleged failure: the image was blurred.A backup device was used.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be mishandling during use and/or sterilization resulting in an impact to the scope.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported the image was blurry, a backup device was used to complete procedure.

• Brand Name: AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM X 0°, 33CM
• Common Device Name: CONFOCAL OPTICAL IMAGING
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8888457
• Report Number: 0002936485-2019-00337
• Device Sequence Number: 18925334
• Product Code: OWN
• UDI-Device Identifier: 07613327063905
• UDI-Public: 07613327063905
• Combination Product (Y/N): N
• 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: 0502937010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 08/13/2019
• 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