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

Model Number C4130

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic bowel resection.Event description: the padding / lattice mesh in the jaws came off in the patient's abdominal cavity during surgery - these pieces needed to manually retrieved from the patient's abdominal cavity.No changes in health resulting form the event, however potential harm to patient if not picked up by theatre staff.Replaced handpiece.Additional information received via email on 10 october 2022 from [name]: it was a laparoscopic bowel resection.Other instruments used were lap instruments, harmonic, diathermy.Intervention: replaced handpiece.Patient status: fine.

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 Description

Procedure performed: laparoscopic bowel resection.Event description: the padding / lattice mesh in the jaws came off in the patient's abdominal cavity during surgery - these pieces needed to manually retrieved from the patient's abdominal cavity.No changes in health resulting from the event, however potential harm to patient if not picked up by theatre staff.Replaced handpiece.Additional information received via email on 10 october 2022 from [name]: it was a laparoscopic bowel resection.Other instruments used were lap instruments, harmonic, diathermy.Intervention: replaced handpiece.Patient status: fine.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of damaged latis pads.One of the jaws was also observed to be damaged.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument that came into contact with the grasper jaw.Based on the damage observed, it is likely that the heat from the instrument caused the pad and jaw to deform.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 15695203
• MDR Text Key: 307092203
• Report Number: 2027111-2022-00796
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: LAP INSTRUMENTS, HARMONIC, DIATHERMY