MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM; CONFOCAL OPTICAL IMAGING

Catalog Number	0233050400
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/11/2024
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 that resulted in a 2nd degree burn.
Event or Problem Description
It was reported that there was a thermal event that resulted in a 2nd degree burn.
Additional Manufacturer Narrative
Alleged failure: heat excessive.Below is a report on the information gathered from an incident involving stryker equipment that occurred on (b)(6) 2024, during a hysteroscopy and dnc procedure.Incident details: date of incident: (b)(6) 2024.Procedure: hysteroscopy and dnc.Event: the light cord adapter caused a burn injury to the patient¿s inner thigh.Light source intensity: set at 100%.Duration of contact: approximately 1 minute and 29 seconds.During the procedure, the light source remained on for approximately 1 hour and 30 minutes.The light cord adapter was placed in direct contact with the patient¿s inner thigh, resulting in a burn injury.Findings and observations: after conducting post-incident testing, i observed that the light cord consistently generated excessive heat under similar conditions.Additionally, the outer sheath of the cord appears compromised, with looseness and wrinkling that may contribute to the overheating issue.However, when i lowered the light source intensity to 40 using the same light cord, no excessive heat was found.Per rep, it was a second degree burn and the rep's testing has shown that the issue was the light cord.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the adapter was left attached on the safe light 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.¿ laser radiation or high-intensity light can continue to emit from the adapter, which can cause severe eye injury to the patient or user.Ifu states the following: 6.Test the device function prior to use.If there is any sign of malfunction, the device should not be used and returned to stryker for repair evaluation.7.Do not abuse, pull, stretch, kink, puncture, or otherwise alter the cable.Doing so will cause irreversible damage to the glass optical fibers, which will impair light transmission through the cable.8.The surface temperature near the scope adapter and at the tip of the endoscope can exceed 41°c if the light source is operated at high levels of brightness for extended periods of time.The heated endoscope and adapter can cause burns to the patient, user, or combustible materials.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.

• Brand Name: FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM
• 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: 21345918
• Report Number: 0002936485-2025-00096
• Device Sequence Number: 18411621
• Product Code: OWN
• UDI-Device Identifier: 07613327462777
• UDI-Public: 07613327462777
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192292
• 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): 04/25/2025

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 Catalogue Number: 0233050400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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