MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, L10 LED LIGHT SOURCE WITH AIM; CONFOCAL OPTICAL IMAGING

Catalog Number	0220220300
Medical Device Problem Codes	Device Sensing Problem (2917); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
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.
Additional Manufacturer Narrative
Alleged failure: the light cord is getting hot when being used.Did not occur during a case, and no delays.No consequence to patient or user, no medical intervention.[update: i think the issue with this unit actually was a result of the l10 failing to turn off once the light cable was disconnected from the scope.I am actually at the facility right now and just tested it for myself and was able to recreate the issue.Sending you pictures of the nature of the issue.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Although the complaint could not be confirmed, the probable root cause could be that the safelight adapter was disconnected from the scope allowing the light to stay on.The safelight adapter should have been disconnected from the safelight cable in order for the safelight functionality to take place and have the light shut off.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 a thermal event.

• Brand Name: PKG, L10 LED LIGHT SOURCE WITH AIM
• 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: 18530808
• Report Number: 0002936485-2024-00047
• Device Sequence Number: 12705846
• Product Code: OWN
• UDI-Device Identifier: 07613327051377
• UDI-Public: 07613327051377
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182160
• 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): 07/02/2024

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: 0220220300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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