MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIM HD LAPAROSCOPE AUTOCLAVABLE 10MM X 30DEG 33CM; CONFOCAL OPTICAL IMAGING

Catalog Number	0502937030
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	07/30/2025
Type of Reportable Event	Malfunction
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 fogging was noticed during the surgical procedure.Initially, after insertion into the peritoneal cavity, visualization was normal.Despite our attempts, we were unable to improve the image quality.After replacing the optics, the image returned to normal.The patient was a 66-year-old female weighing 66 kg.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.No further attempts to retrieve the device are required.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: fogging.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).Use error.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that fogging was noticed during the surgical procedure.Initially, after insertion into the peritoneal cavity, visualization was normal.Despite our attempts, we were unable to improve the image quality.After replacing the optics, the image returned to normal.The patient was a 66-year-old female weighing 66 kg.
Additional Manufacturer Narrative
The product has now been physically received at stryker endoscopy, usa.Investigation as follows is now based on product received.Alleged failure: the visibility issue/fogging was noticed during the surgical procedure.Initially, after insertion into the peritoneal cavity, visualization was normal.Despite our attempts, we were unable to improve the image quality.After replacing the optics, the image returned to normal.The patient was a 66-year-old female weighing 66 kg.Surgical procedure: laparoscopic fundoplication.The optics leaks - the moisture is inside the optics and not outside.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be misaligned inner lenses, rough handling during sterilization and/or product transport.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that fogging was noticed during the surgical procedure.Initially, after insertion into the peritoneal cavity, visualization was normal.Despite our attempts, we were unable to improve the image quality.After replacing the optics, the image returned to normal.The patient was a 66-year-old female weighing 66 kg.

• Brand Name: AIM HD LAPAROSCOPE AUTOCLAVABLE 10MM X 30DEG 33CM
• Common Device Name: CONFOCAL OPTICAL IMAGING
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22904944
• Report Number: 0002936485-2025-00730
• Device Sequence Number: 20811050
• Product Code: OWN
• UDI-Device Identifier: 07613327063912
• UDI-Public: 07613327063912
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K142310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 0502937030
• Device Lot Number: 411630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 02/04/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/30/2025; 03/02/2026
• 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 Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 66 KG