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

Device Problems Thermal Decomposition of Device (1071); Failure to Shut Off (2939)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

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 Description

It was reported that there was drape burn.

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 Description

It was reported that there was drape burn.

• Brand Name: PKG., SAFELIGHT FIBER OPTIC CABLE CLEAR, 5MM X 10FT 3.05M
• Type of Device: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12202334
• MDR Text Key: 264935814
• Report Number: 0002936485-2021-00392
• Device Sequence Number: 1
• Product Code: FCW
• UDI-Device Identifier: 07613327051650
• UDI-Public: 07613327051650
• Combination Product (y/n): N
• PMA/PMN Number: K082813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1