MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, SAFELIGHT HENKE/DYONICS/STORZ SCOPE ADAPTER; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number	0233050087
Medical Device Problem Codes	Connection Problem (2900); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
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
This event was initially reported as a malfunction for a thermal event.Upon additional information provided, it was reported that the device is missing a magnet, therefore it would not have been able to be turned on.This event is no longer reportable.This event description most likely indicates "no light output".The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.No report will be filed.
Additional Manufacturer Narrative
This event was initially reported as a malfunction for a thermal event.Upon additional information provided, it was reported that the device is missing a magnet, therefore it would not have been able to be turned on.This event is no longer reportable.This event description most likely indicates "no light output".The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.No report will be filed.The manufacture date is not known.

• Brand Name: PKG, SAFELIGHT HENKE/DYONICS/STORZ SCOPE ADAPTER
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• 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: 20034304
• Report Number: 0002936485-2024-00580
• Device Sequence Number: 6395480
• Product Code: FCW
• UDI-Device Identifier: 07613327161618
• UDI-Public: 07613327161618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/26/2024

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: Other
• Device Catalogue Number: 0233050087
• Device Lot Number: 24E5329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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