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

Model Number	0233050100
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	06/21/2021
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 drape burn.
Additional Manufacturer Narrative
Alleged failure: "safelight feature on the cord, the light didn't not turn off which burned a hole on the drape salesforce case number (b)(6) 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 drape burn.

• Brand Name: PKG., SAFELIGHT FIBER OPTIC CABLE CLEAR, 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
• MDR Report Key: 12202334
• Report Number: 0002936485-2021-00392
• Device Sequence Number: 11645772
• Product Code: FCW
• UDI-Device Identifier: 07613327051650
• UDI-Public: 07613327051650
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/30/2021

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: 0233050100
• Device Catalogue Number: 0233050100
• Device Lot Number: 159215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1