MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG AIM COUPLER 18MM C-MOUNT; CONFOCAL OPTICAL IMAGING

Catalog Number	1588020122
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was poor image quality.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was poor image quality.
Additional Manufacturer Narrative
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: poor visual probable root cause: ¿ cables ¿ connectors ¿ digital board ¿ power supply ¿ filter / fuse ¿ ac inlet board ¿ main board ¿ transition board ¿ fiber board ¿ intermittence between transition board and ch connector ¿ software ¿scope ¿light source ¿ camera head (sensor, sensor cable) ¿ coupler (dust on optics, scratched optics, broken / shifted lenses, focusing mechanism, endoclamp, zoom ring) ¿ 1488 & 1588 extension cable ¿ intermittence while using rf devices (ex: valleylab) ¿ problem toggling light source or from camera head ¿ connected monitors ¿ leaking ¿ use error ¿ poor grounding (e.G."finger" grounding tab connecting front and rear enclosure.Camera head connection from cable to transition board.) ¿electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG AIM COUPLER 18MM C-MOUNT
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20845800
• Report Number: 0002936485-2024-00871
• Device Sequence Number: 7984433
• Product Code: OWN
• UDI-Device Identifier: 07613327174359
• UDI-Public: 07613327174359
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142310
• 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): 02/24/2025

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: 1588020122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2016
• 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