MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EPIX ® LAPAROSCOPIC DISSECTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	CY010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: total laparascopic hysterectomy.Event description: during a total laparoscopic hysterectomy at the end while finishing, the surgeon was using dissectors and when they pulled them out of the trocar, half of the jaw was missing.Immediately x-rayed patient during the surgery and found the piece but was unable to retrieve.Piece was left inside of patient.Intervention: surgery was already over when malfunction was noticed.Patient status: patient x-rayed, piece found but not able to be retrieved.Patient x-rayed, piece found but not able to be retrieved.
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

• Brand Name: EPIX ® LAPAROSCOPIC DISSECTOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 25156084
• Report Number: 2027111-2026-00550
• Device Sequence Number: 21521729
• Product Code: GEI
• UDI-Device Identifier: 00607915126964
• UDI-Public: (01)00607915126964
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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 Model Number: CY010
• Device Catalogue Number: 101419901
• Device Lot Number: 1578055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 12/22/2025
• 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: 5MM APPLIED MEDICAL TROCAR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown