MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4140, 5MMX45CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4140
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robotic right hemi-colectomy.Description of event: it was being used to grasp tissue/specimens during the procedure.The procedure started off as a robotic case and converted to laparoscopic during the procedure.They noticed during the procedure that the latis pads had come away from the jaws and it was seen on the camera stack.The customer will be sending me images of the item and i will upload these upon receipt of the images.Replaced with another c4140 and no problems with that device, the procedure was then completed additional information received by company rep.Via e-mail on 13aug24: graspers were used to grasp tissue in the normal way, no different to how they always use the device.The pad was all retrieved, but not both pads on either side of the jaws was detached, just one side, as shown in the images.Intervention: replaced with another c4140 and no problems with that device, the procedure was then completed patient status: no injury to the patient occurred.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a detached pad.Visual inspection confirmed the complainant¿s experience of pad detachment.Based on the condition of the returned unit, it is likely that the pad detachment occurred during use in the procedure due to the latis material unraveling and releasing the pad from the jaw.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.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: robotic right hemi-colectomy.Description of event: it was being used to grasp tissue/specimens during the procedure.The procedure started off as a robotic case and converted to laparoscopic during the procedure.They noticed during the procedure that the latis pads had come away from the jaws and it was seen on the camera stack.The customer will be sending me images of the item and i will upload these upon receipt of the images.Replaced with another c4140 and no problems with that device, the procedure was then completed additional information received by company rep.Via e-mail on 13aug24: graspers were used to grasp tissue in the normal way, no different to how they always use the device.The pad was all retrieved, but not both pads on either side of the jaws was detached, just one side, as shown in the images.Intervention: replaced with another c4140 and no problems with that device, the procedure was then completed patient status: no injury to the patient occurred.
Additional Manufacturer Narrative
Correction: h6.Investigation conclusions.
Event or Problem Description
Procedure performed: robotic right hemi-colectomy.Description of event: it was being used to grasp tissue/specimens during the procedure.The procedure started off as a robotic case and converted to laparoscopic during the procedure.They noticed during the procedure that the latis pads had come away from the jaws and it was seen on the camera stack.The customer will be sending me images of the item and i will upload these upon receipt of the images.Replaced with another c4140 and no problems with that device, the procedure was then completed additional information received by company rep.Via e-mail on 13aug24: graspers were used to grasp tissue in the normal way, no different to how they always use the device.The pad was all retrieved, but not both pads on either side of the jaws was detached, just one side, as shown in the images.Intervention: replaced with another c4140 and no problems with that device, the procedure was then completed patient status: no injury to the patient occurred.

• Brand Name: C4140, 5MMX45CM 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20072170
• Report Number: 2027111-2024-00796
• Device Sequence Number: 2998517
• Product Code: NWV
• UDI-Device Identifier: 00607915110154
• UDI-Public: (01)00607915110154(17)270322(30)01(10)1520096
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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 Model Number: C4140
• Device Catalogue Number: 101476262
• Device Lot Number: 1520096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 12/06/2024; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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: APPLIED'S ADVANCED FIXATION TROCARS.; CAMERA SCOPE.; COMPETITOR'S GRASPER.
• Patient Sex: Unknown