MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG SAFELIGHT FIBER OPTIC CABLE GREY 5MM X 10FT 3.05M; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0233050200
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was the potential of a thermal event.
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.
Additional Manufacturer Narrative
Alleged failure: "it was reported by the sales rep cullen brown the light source remained on when it was removed from the adapter on the scope ref rma (b)(4) salesforce case number (b)(4)" conclusion: reported failure mode could not be reproduced but reed switch function was noted to be slightly insensitive in response to safelight adapter attachment.It's possible that these issues could cause it to get stuck in either the "on" or "off" position, leading to the reported scenario where the light source fails to turn off after the safelight adapter was removed.Probable root cause is likely due to a damaged/defective reed switch.The product was returned for investigation and the failure(s) identified is consistent with the complaint record.Failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was the potential of a thermal event.

• Brand Name: PKG SAFELIGHT FIBER OPTIC CABLE GREY 5MM X 10FT 3.05M
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• 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: hannah stalnaker ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12858126
• Report Number: 0002936485-2021-00667
• Device Sequence Number: 12258298
• Product Code: FCW
• UDI-Device Identifier: 07613327051643
• UDI-Public: 07613327051643
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082813
• 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): 01/10/2022

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 Model Number: 0233050200
• Device Catalogue Number: 0233050200
• Device Lot Number: 165445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/11/2022
• 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