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

Model Number	C4130
Medical Device Problem Codes	Material Frayed (1262); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: lap gen surg.Event description: event 1 of 2: 2023-000613, event 2 of 2: 2023-000614.Event date unknown: in both procedures the devices were being used to move and manipulate internal organs.Both procedures where the devices failed were being used by different surgeon.One incident was 6/8 weeks ago and the other was 2 weeks ago.No changes in health resulting from the event.One procedure one of the pads fell off and was retrieved by the device itself.The other procedure the device pad/s started to fray and again was retrieved by the device.The frayed part is included in the grasper packaging.No details available on what other instruments were used when the complaint event occurred.Additional information received from applied medical representative via email 16mar2023: it is the representative's understanding that a whole pad came off and was retrieved.It was not with the device when it was given to the representative.Intervention: retrieved by the device.Patient status: zero issues.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the latis on one of the grasper pads was frayed.Based on the condition of the returned unit, the reported event likely occurred as a result of the usage of the grasper during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: section d4 (catalog number, lot number, udi number) and h4 is being updated as the incorrect product information was provided in the initial report.
Event or Problem Description
Procedure performed: lap gen surg event description: event 1 of 2: 2023-000613 [mfr #2027111-2023-00392] event 2 of 2: 2023-000614 [mfr #2027111-2023-00393] in both procedures the devices were being used to move and manipulate internal organs.Both procedures where the devices failed were being used by different surgeon.One incident was 6/8 weeks ago and the other was 2 weeks ago.No changes in health resulting from the event.One procedure one of the pads fell off and was retrieved by the device itself.The other procedure the device pad/s started to fray and again was retrieved by the device.The frayed part is included in the grasper packaging.No details available on what other instruments were used when the complaint event occurred.Additional information received from applied medical representative via email 16mar23: it is the representative's understanding that a whole pad came off and was retrieved.It was not with the device when it was given to the representative.Additional information received from iric in scotland 23mar23: the event happened on march 1, 2023.Applied medical 'pad' frayed during use on patient.Potential for frayed threads to get lost inside the patients abdomen.Possible cause - wear and tear/ faulty.Intervention: retrieved by the device patient status: zero issues.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16594365
• Report Number: 2027111-2023-00393
• Device Sequence Number: 5088956
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)251002(30)01(10)1465120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 10/02/2025
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1465120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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