MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM; CONFOCAL OPTICAL IMAGING

Catalog Number	0233050490
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2025
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 there was a thermal event.
Event or Problem Description
It was reported that there was a thermal event.
Additional Manufacturer Narrative
Updated g4 pma/510(k) to k192292.Updated h6 medical device problem to overheating of device.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.Multiple attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: too much heat.Probable root cause: reed switch assembly malfunction use error.The device manufacturer date is not known.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM
• 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: 21529700
• Report Number: 0002936485-2025-00164
• Device Sequence Number: 9584490
• Product Code: OWN
• UDI-Device Identifier: 07613327462760
• UDI-Public: 07613327462760
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: 0233050490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/10/2025
• 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
• Patient Sex: Unknown