MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, L10 LED LIGHT SOURCE WITH AIM; CONFOCAL OPTICAL IMAGING

Model Number	0220220300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was 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: customer states safelight fell off scope and contributed to drape burn.[update - devices were not warm/hot to the touch.No devices were smoking.No patient/user injuries, only drape was damaged and replaced.] the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause: not following the user guide safety/warnings.Advise to calibrate the light source unit.Before operating this device, please read this operating manual thoroughly and carefully.When using a light source, fire and/or severe injury may result to the patient, user or inanimate objects if the instructions in this manual are not followed.All light sources can generate significant amounts of heat (exceeding 41 °c/106 °f) at the scope tip, the scope light post, the light cable tip, and/or near the light cable adapter.Higher levels of brightness result in higher levels of heat.Adjust the brightness level of the camera and the monitor to the minimum brightness necessary to adequately illuminate the surgical site.In addition, adjust the internal shutter of the camera higher in order to run the light source at a lower intensity.Avoid touching the scope tip or the light cable tip to the patient, and never place them on top of the patient, as doing so may result in burns to the patient or user.In addition, never place the scope tip, the scope light post, the light cable adapter, or the light cable tip on the surgical drapes or other flammable material, as doing so may result in fire.Always place the light source in standby mode and disable env mode before the scope is removed from the light cable or the device is unattended.The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after being placed in standby mode, and therefore may still result in fire or burns to the patient, user, or inanimate objects.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a thermal event.

• Brand Name: PKG, L10 LED LIGHT SOURCE WITH AIM
• Common Device Name: CONFOCAL OPTICAL IMAGING
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15700950
• Report Number: 0002936485-2022-00621
• Device Sequence Number: 20881163
• Product Code: OWN
• UDI-Device Identifier: 07613327051377
• UDI-Public: 07613327051377
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142310
• 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): 12/29/2022

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: 0220220300
• Device Catalogue Number: 0220220300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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