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	Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was loss of light for 30 seconds.
Event or Problem Description
It was reported that there was loss of light for 30 seconds.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: stops intermittently probable root cause: broken optical fibers, poor light cable alignment in jaw, residue on fiber tip, nonuniform light output use error intermittent electrical component contact in safelight circuit, reed switch assembly malfunction magnet missing from safelight adapter the reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.H3 other text : 81.

• 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: 11310873
• Report Number: 0002936485-2021-00084
• Device Sequence Number: 14304962
• Product Code: FCW
• UDI-Device Identifier: 07613327051650
• UDI-Public: 07613327051650
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/13/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1