MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EPIX LAPAROSCOPIC GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lower anterior resection with da vinci robotic surgery.Event description: [hospital] "the surgeon discovered that the tip of the instrument was broken and unusable upon initial use." additional information received from [distributor] via email on 10sep2024 "jaw detached.Malfunction noticed or happened beginning of the surgery." intervention: the case was completed with the new one.Patient status: no patient injury.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the shaft being bent.Based on the condition of the returned unit, it is likely that the reported event may have been caused by mishandling during shipping or at the customer's facility.However, the exact root cause of the bent shaft could not be determined.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.Correction: d1.
Event or Problem Description
Procedure performed: lower anterior resection with da vinci robotic surgery.Event description: [hospital] "the surgeon discovered that the tip of the instrument was broken and unusable upon initial use." additional information received from [distributor] via email on 10sep2024 "jaw detached.Malfunction noticed or happened beginning of the surgery." additional information obtained from [distributor] via email on 22nov2024: as the incident occurred long ago, the user no longer recalls the details, and the unit has been returned to applied, making it impossible for us to verify the issue.Intervention: the case was completed with the new one.Patient status: no patient injury.

• Brand Name: EPIX LAPAROSCOPIC GRASPER
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• 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: 20359178
• Report Number: 2027111-2024-00855
• Device Sequence Number: 7208965
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)251116(30)01(10)1470766
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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 Expiration Date: 11/16/2025
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1470766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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
• Patient Sex: Unknown