MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION AC 3-CHIP AUTOCLAVABLE CAMERA, C-MOUNT - INTERNATIONAL KIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0700410105
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
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 blurry image.
Additional Manufacturer Narrative
Alleged failure: the image was showing only at the edge of the screen.Since the operation could not be performed in this condition, another camera head was used.[update - when we tried to use another camera during the surgery, the image was at the edge of the screen.Since we could not operate in this condition, we used this camera head, which also had noise.Despite the noise, the operation was continued and completed.The surgeon said that this may be an initial defect as the product has just been purchased.He wishes to investigate the cause of the problem.Note - it is unknown which camera was the original one - issue with image at the edge of the screen] the failure(s) identified in the investigation is consistent with the complaint record.Root cause: the most likely caused could be a manufacturing workmanship issue.Please refer to nc (b)(4).The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was blurry image.

• Brand Name: PKG, PRECISION AC 3-CHIP AUTOCLAVABLE CAMERA, C-MOUNT - INTERNATIONAL KIT
• 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: 14574334
• Report Number: 0002936485-2022-00285
• Device Sequence Number: 5800382
• Product Code: GCJ
• UDI-Device Identifier: 07613327137378
• UDI-Public: 07613327137378
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 0700410105
• Device Catalogue Number: 0700410105I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/18/2022
• 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