MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SPY LAPAROSCOPE AUTOCLAVABLE DIA 10MM 0 DEG 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502938010
Medical Device Problem Codes	Fogging (1253); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
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 is a sealing problem on the optics.Presence of mist and water droplets inside the lens after sterilization.The optic was about to be used for the first time.There was an impact on the patient, as the procedure was converted to open surgery.
Event or Problem Description
It was reported that there is a sealing problem on the optics.Presence of mist and water droplets inside the lens after sterilization.The optic was about to be used for the first time.There was an impact on the patient, as the procedure was converted to open surgery.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation.The device has not been received.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: mist and water droplets inside the lens after sterilization.Probable root cause: laser welding seal failure, distal/proximal window solder failure, damage to optical train, damage to needle, damage to distal or proximal windows, moisture intrusion, end of life wear-out, environmental disturbance: endoscope colder than dew point, environmental disturbance: fluid entrapment between the coupler and eyepiece junction (eyepiece only), or use error.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: SPY LAPAROSCOPE AUTOCLAVABLE DIA 10MM 0 DEG 33CM
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22015329
• Report Number: 0002936485-2025-00443
• Device Sequence Number: 12925619
• Product Code: GCJ
• UDI-Device Identifier: 07613327575354
• UDI-Public: 07613327575354
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221217
• 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): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0502938010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown