MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SPY LAPAROSCOPE, AUTOCLAVABLE, DIA 5.4MM 30 DEG, 30CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502538030
Medical Device Problem Codes	Fogging (1253); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2023
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 foggy image.
Additional Manufacturer Narrative
Alleged failure: (b)(6).Please process the below repair.They should be under warranty still.The scope has a foggy lense.There was no patient involvement or delay.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be a leak coming from the distal end of the scope.This could have occurred during transport of the product or during handling of the scope during sterilization.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 foggy image.

• Brand Name: SPY LAPAROSCOPE, AUTOCLAVABLE, DIA 5.4MM 30 DEG, 30CM
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18332169
• Report Number: 0002936485-2023-01265
• Device Sequence Number: 20936424
• Product Code: GCJ
• UDI-Device Identifier: 07613327575231
• UDI-Public: 07613327575231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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 Catalogue Number: 0502538030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2023
• Supplement Date Received by Manufacturer: 11/19/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 06/21/2024
• 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