MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION AC COUPLER, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0700020122
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: surgeon cannot get optimal focus using the coupler.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: the coupler conforms to specifications.The complaint reported was related to the camera head s/n (b)(4) sent along with the coupler.The device manufacturer date is not known.
Event or Problem Description
It was reported that there was blurry image.

• Brand Name: PKG, PRECISION AC COUPLER, C-MOUNT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14754618
• Report Number: 0002936485-2022-00354
• Device Sequence Number: 12294333
• Product Code: GCJ
• UDI-Device Identifier: 07613327137361
• UDI-Public: 07613327137361
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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: 0700020122
• Device Catalogue Number: 0700020122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown