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 Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2022
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 that there was blurry image.Please note that the procedure was completed successfully.
Event or Problem Description
It was reported that there was blurry image.Please note that the procedure was completed successfully.
Additional Manufacturer Narrative
Reported failure mode: "blurry & not clear image /half black image".Probable root cause: the reported failure mode was confirmed and probable root cause was likely due to damage during use/handling of the endoscope.The device was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future re occurrence.For information and warnings related to the proper use and maintenance of this device, please reference and adhere to information presented in the associated product ifu.Manufacturing date is unknown.

• 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; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13688717
• Report Number: 3012345110-2022-00001
• Device Sequence Number: 5308988
• Product Code: GCJ
• UDI-Device Identifier: 00858701006131
• UDI-Public: 00858701006131
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K161792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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