MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic salpingo oophorectomy.Event description: during the procedure, the shaft of the device was bent.It was noted as a visible break but with all parts intact.No remnants of the device fell into the patient.The case was completed with the same device and had no other problems.There was no patient injury and the patient is doing fine.Product is available for return.Product updated to npr: additional information received via medwatch #mw5147682 on 29dec2023: today we had a disposable epix laparoscopic grasper break during use.All parts of the instrument are intact (visible break), and no remnants of the instrument were found or left in the patient.Patient status: no patient injury and the patient is doing fine.Intervention: the case was completed with the same device.
Additional Manufacturer Narrative
The event unit did not return to applied medical.A follow up report will be provided following the completion of the investigation.This report is to follow up mw5147682.
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.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic salpingo oophorectomy.Event description: during the procedure, the shaft of the device was bent.It was noted as a visible break but with all parts intact.No remnants of the device fell into the patient.The case was completed with the same device and had no other problems.There was no patient injury and the patient is doing fine.Product is available for return.Product updated to npr.Additional information received via medwatch #mw5147682 on 29dec2023: today we had a disposable epix laparoscopic grasper break during use.All parts of the instrument are intact (visible break), and no remnants of the instrument were found or left in the patient.Patient status: no patient injury and the patient is doing fine.Intervention: the case was completed with the same device.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19265509
• Report Number: 2027111-2024-00626
• Device Sequence Number: 7107898
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)260809(30)01(10)1500606
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 08/09/2026
• Device Model Number: C4130
• Device Catalogue Number: 101476261
• Device Lot Number: 1500606
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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