MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PINPOINT LAPAROSCOPE - 5MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SC9534
Medical Device Problem Codes	Mechanical Problem (1384); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image was cloudy during procedure.
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 that the image was cloudy during procedure.
Additional Manufacturer Narrative
The device was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future re occurrence.Reported failure mode: "the optics became cloudy during the procedure, so another optic had to be used." probable root cause: the reported failure mode was likely caused by user error and mishandling of the device.The device manufacture date is not known.

• Brand Name: PINPOINT LAPAROSCOPE - 5MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13044513
• Report Number: 3012345110-2021-00015
• Device Sequence Number: 14442639
• Product Code: GCJ
• UDI-Device Identifier: 00858701006131
• UDI-Public: 00858701006131
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: SC9534
• Device Catalogue Number: SC9534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/17/2022
• 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