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

Model Number C4130

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

Procedure performed: lap gen surg.Event description: event 1 of 2: 2023-000613, event 2 of 2: 2023-000614.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 itself.Patient status: zero issues.

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.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of pad detachment.Based on the condition of the returned unit, the pad detached due to adhesive failure, likely resulting from usage 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: d4 is being updated to unk as the suspected device information was incorrect.

Event 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.Intervention: zero issues patient status: retrieved by the device itself.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: 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: 16593787
• MDR Text Key: 312303829
• Report Number: 2027111-2023-00392
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)251002(30)01(10)1465120
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

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
• Device Operator: Health Professional
• Device Model Number: C4130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1