MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05M; CONFOCAL OPTICAL IMAGING

Catalog Number	0233050300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: both cables illuminate without safelight adapters installed.Light source recognizes them as 'standard' cables.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be a bad reed switch inside the safe light cable.The warning on the ifu states "the surface temperature near the scope adapter and at the tip of the scope can exceed 41 °c if the light source is operated at high levels of brightness for extended periods of time.The heated scope and adapter can cause burns to the patient, user, or combustible materials." step #9 of the ifu states the following: 9.Do not leave a safelight adapter attached to the cable without an endoscope attached: light can continue to emit from the adapter, which can generate heat that can cause burns or fires if allowed to come into contact with the patient, user, or combustible materials.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacture date is not known.
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: both cables illuminate without safelight adapters installed.Light source recognizes them as standard cables.The failures identified in the investigation is consistent with the complaint record.The probable root causes could be a bad reed switch inside the safe light cable.The warning on the ifu states the surface temperature near the scope adapter and at the tip of the scope can exceed 41c if the light source is operated at high levels of brightness for extended periods of time.The heated scope and adapter can cause burns to the patient, user, or combustible materials.Step 9 of the ifu states the following: 9.Do not leave a safelight adapter attached to the cable without an endoscope attached.Light can continue to emit from the adapter, which can generate heat that can cause burns or fires if allowed to come into contact with the patient, user, or combustible materials.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05M
• 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: 18890809
• Report Number: 0002936485-2024-00211
• Device Sequence Number: 11499790
• Product Code: OWN
• UDI-Device Identifier: 07613327051674
• UDI-Public: 07613327051674
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/15/2024

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: 0233050300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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