MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1288210105
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
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 there was fogging during a procedure, which could not be wiped away.
Additional Manufacturer Narrative
Alleged failure: blurry foggy image.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: the most likely root causes for the issues found could be wear and tear and/or by the cable being pulled or bent hard during sterilization.Camera head is not producing a blurry foggy image.The cause of the blurry foggy image is the coupler.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 fogging during a procedure, which could not be wiped away.

• Brand Name: PKG 1288HD CAMERA HEAD
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9459370
• Report Number: 0002936485-2019-00544
• Device Sequence Number: 14150955
• Product Code: GCJ
• UDI-Device Identifier: 07613327063424
• UDI-Public: 07613327063424
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132785
• 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): 02/20/2020

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: 1288210105
• Device Catalogue Number: 1288210105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1