MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ADAPTER, RIGHT ANGLE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0331000400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
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.
Event or Problem Description
It was reported that there was a thermal event.
Additional Manufacturer Narrative
Alleged failure: "surgeon was doing a case and the light post on the scope got so hot the surgeon said it was burning through their gloves.They tested the temps with a heat gun and registered 108 degrees.After the case they tried the same setup in a different room with a different light source and the heat gun registered temps in the 80s.They were using an l9000 , safelight cable and right angle adapters (see attached picture).".The failure(s) identified in the investigation is consistent with the complaint record.Probable root cause: from the attached photos, light leakage can be seen from the right angle adapter that was being used.The right angle adapter was not returned for investigation with the light source, however a damaged adapter is the probable root cause.Additionally, the light source¿s thermal temperatures were measured via thermocouples placed on the distal end of the light cable/adapter, where temperatures did not exceed normal ranges.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG, ADAPTER, RIGHT ANGLE
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10794498
• Report Number: 0002936485-2020-00455
• Device Sequence Number: 10980582
• Product Code: FCW
• UDI-Device Identifier: 07613327057225
• UDI-Public: 07613327057225
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961971
• 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): 01/13/2021

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: 0331000400
• Device Catalogue Number: 0331000400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1