MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4121, 45CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4121
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic roux-en-y.Event description: two similar complaints occurred at [user facility]: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).The surgeon used two graspers during "soft launch testing" and one of the devices experienced fraying at the tip of the latis pad.The surgeon noticed that the latis pad was fraying two hours into the three-hour procedure.The other device did not experience fraying or any other issues.They were able to finish the procedure normally.There was no impact to the case.No patient injury.The surgeon noted that they have seen this issue in the past but the device always performed as needed.Additional information was received via email on 23jun2023 from [name], clinical development analyst ii, applied medical: no, the user did not experience any tissue sticking or tearing when using the frayed device."the graspers were being used to handle tissue during a bariatric roux-en-y procedure.These tissues/organs interacted with include the stomach, small intestine, fat tissue (omentum and visceral fat), ligaments (gastrophrenic and gastrosplenic), and manipulation of the circular stapler anvil." harmonic energy device, circular stapler, linear stapler, laparoscopic graspers with teeth, monopolar pencil (l-hook), suction-irrigator, laparoscopic needle holders and [competitor] liver retractor were used during the procedure.Intervention: they were able to finish the procedure normally.There was no impact to the case.Patient status: no patient injury.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a frayed latis pad.Based on the condition of the returned unit, the reported event likely occurred as a result of the use of the grasper.However, applied medical is unable to determine the exact root cause of the pad fraying based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic roux-en-y.Two similar complaints occurred at [user facility]: complaint 1 of 2: (b)(4) - c4121 lot #1472638 [mfr #2027111-2023-00528] complaint 2 of 2: (b)(4) [mfr #2027111-2023-00529].The surgeon used two graspers during "soft launch testing" and one of the devices experienced fraying at the tip of the latis pad.The surgeon noticed that the latis pad was fraying two hours into the three-hour procedure.The other device did not experience fraying or any other issues.They were able to finish the procedure normally.There was no impact to the case.No patient injury.The surgeon noted that they have seen this issue in the past but the device always performed as needed.Both devices used during the procedure are returning for complaint #(b)(4).[] additional information was received via email on 23jun2023 from [name], clinical development analyst ii, applied medical: no, the user did not experience any tissue sticking or tearing when using the frayed device."the graspers were being used to handle tissue during a bariatric roux-en-y procedure.These tissues/organs interacted with include the stomach, small intestine, fat tissue (omentum and visceral fat), ligaments (gastrophrenic and gastrosplenic), and manipulation of the circular stapler anvil." harmonic energy device, circular stapler, linear stapler, laparoscopic graspers with teeth, monopolar pencil (l-hook), suction-irrigator, laparoscopic needle holders and nathanson liver retractor were used during the procedure.Intervention: they were able to finish the procedure normally.There was no impact to the case.Patient status: no patient injury.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 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: 17367904
• Report Number: 2027111-2023-00528
• Device Sequence Number: 12280204
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)251214(30)01(10)1472638
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 12/14/2025
• Device Model Number: C4121
• Device Catalogue Number: 101476260
• Device Lot Number: 1472638
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CIRCULAR STAPLER; HARMONIC ENERGY DEVICE,; LAPAROSCOPIC GRASPERS WITH TEETH; LAPAROSCOPIC NEEDLE HOLDERS; LINEAR STAPLER; MONOPOLAR PENCIL (L-HOOK); NATHANSON LIVER RETRACTOR; SUCTION-IRRIGATOR
• Patient Sex: Unknown