MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PINPOINT LAPAROSCOPE - 10MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SC9134
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
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 the image appeared blurry during a medical procedure.A replacement device was used to complete the procedure and there were no adverse consequences as a result.
Event or Problem Description
It was reported that the image appeared blurry during a medical procedure.A replacement device was used to complete the procedure and there were no adverse consequences as a result.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The technical service report indicates: outer tube damaged, distal tip, distal tip damaged, particulate, optics particulate under distal lens, cosmetic issues, scratches/dents, engraving/identification.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PINPOINT LAPAROSCOPE - 10MM, 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15306987
• Report Number: 3012345110-2022-00006
• Device Sequence Number: 2658065
• Product Code: GCJ
• UDI-Device Identifier: 00858701006063
• UDI-Public: 00858701006063
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: SC9134
• Device Catalogue Number: SC9134
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 11/30/2022
• 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