MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES SURSEAL® II; ENDOSCOPE CHANNEL ACCESSORY

Model Number	SEAL-005
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Procedure performed: bladder biopsy.Event description: complaint created based on medwatch received by email on 06nov2024.Report number: (b)(4).Date of event (b)(6) 2024.Sureseal ii would not let the biopsy grasper pass through for a bladder biopsy.Intervention: ni.Patient status: ni.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch# (b)(4).
Event or Problem Description
Procedure performed: bladder biopsy.Event description: complaint created based on medwatch received by email on 06nov2024.Report number: (b)(4).Date of event sep-2024.Sureseal ii would not let the biopsy grasper pass through for a bladder biopsy.Intervention: ni.Patient status: ni.

• Brand Name: SURSEAL® II
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20800267
• Report Number: 2027111-2024-00934
• Device Sequence Number: 15201080
• Product Code: ODC
• UDI-Device Identifier: 00607915119904
• UDI-Public: (01)00607915119904
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K920030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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 Model Number: SEAL-005
• Device Catalogue Number: 100601902
• Device Lot Number: 1514753
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOPSY GRASPER
• Patient Sex: Unknown