MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG L12 LED LIGHT SOURCE WITH AIM; CONFOCAL OPTICAL IMAGING

Catalog Number	0220240300
Medical Device Problem Codes	Optical Problem (3001); Output Problem (3005)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
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 due to icg not working, they had a problem identifying the ureter, and because of this, the surgeon thinks the ureter and bladder was injured so we had to call an on-call urologist to check on the bladder and ureter.Theatre time was prolonged.Patient was exposed to longer anesthetic agent.Patient needed to be admitted for further care and treatment." per additional information received from the account, the failure resulted in an injury might have been caused by thermal from diathermy.A leak test was done with bladder filed with methylene blue but no obvious leaks, retrogrades were performed with x-ray attendance and no leak on ureter.Even though there are no obvious leak, both surgeons still decide to treat it as bladder injury.Ureteric stent was inserted.Catheter was inserted and planned to be left for 2 weeks, and stent be removed after 6 weeks.Catheter was put in to observe any post-surgical bleeding.The icg used was verdye green 5mg/ml (indocyanin green) and is not a stryker product.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: no icg fluorescence.Probable root cause: damaged/missing esst spring, safelight function failure, esst voltage malfunction, assembly/grounding, light engine malfunction, main board malfunction, front board malfunction, receptacle board malfunction, incorrect communication with ccu damaged jaw assembly/grounding software malfunction - main board, front board, or receptacle board, incorrect calibration, poor alignment of cable in jaw, per rsk13257: cybersecurity attack to: device settings, uc1 on main board, uc2 on main board, uc3 on main board, receptacle board, ccu usb ports, hub port, service port, device controls, uc1 programming port, uc2 programming port, uc3 programming port, receptacble board receptacle.Port, light engine, debug device functionality, physical location of l12, l12 firmware operating system.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that due to icg not working, they had a problem identifying the ureter, and because of this, the surgeon thinks the ureter and bladder was injured so we had to call an on-call urologist to check on the bladder and ureter.Theatre time was prolonged.Patient was exposed to longer anesthetic agent.Patient needed to be admitted for further care and treatment." per additional information received from the account, the failure resulted in an injury might have been caused by thermal from diathermy.A leak test was done with bladder filed with methylene blue but no obvious leaks, retrogrades were performed with x-ray attendance and no leak on ureter.Even though there are no obvious leak, both surgeons still decide to treat it as bladder injury.Ureteric stent was inserted.Catheter was inserted and planned to be left for 2 weeks, and stent be removed after 6 weeks.Catheter was put in to observe any post-surgical bleeding.The icg used was verdye green 5mg/ml (indocyanin green) and is not a stryker product.

• Brand Name: PKG L12 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23228429
• Report Number: 0002936485-2025-00824
• Device Sequence Number: 9478783
• Product Code: OWN
• UDI-Device Identifier: 07613327572124
• UDI-Public: 07613327572124
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K230754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0220240300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown