MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EPIX LAPAROSCOPIC GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ni.Event description: the information was collected as feedback in a meeting with the surgeon.The feedback submission number is (b)(4).Surgeon felt that the latis pads are extremely rough and sticky and causes 'holes in the bowel'.Will not use them and contraindicates their use in colorectal surgery.The device was being used for grasping bowel.Potential holes in bowel.This is a generic complaint, regarding the new alterations to the grasper since the mim upgrade was implemented.Doctor stated that this was absolutely not a device to be used on the bowel due to risk of tearing.It is unknown if there was any clinical impact to the patient as a result of the event.It is unknown how the user resolved the situation.Patient status: ni.Intervention: ni.
Event or Problem Description
Procedure performed: na event description: complaint (b)(4), complaint (b)(4).The information was collected as feedback in a meeting with the surgeon.The feedback submission number is 7138.Surgeon felt that the latis pads are extremely rough and sticky and causes 'holes in the bowel'.Will not use them and contraindicates their use in colorectal surgery.The device was being used for grasping bowel.Potential holes in bowel.This is a generic complaint, regarding the new alterations to the grasper since the mim upgrade was implemented.Doctor stated that this was absolutely not a device to be used on the bowel due to risk of tearing.It is unknown if there was any clinical impact to the patient as a result of the event.It is unknown how the user resolved the situation.Additional information was provided by [name], (b)(4) territory manager via email on 16-dec-2024."it was just a fear the surgeon had which kept him from using the devices." additional information was provided by [name], (b)(4) territory manager via email on 23-dec-2024."yes, i replied to this one with the second complaint follow-up.Both cases did not involve a patient, these were just the thoughts of both separate surgeons on each report." patient status: na intervention: na.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.The complainant did not allege any malfunction with an applied medical device.Based on the event additional information, there was no product malfunction occurred.This event was initially reported based on the description of the event.However, based on further examination of the event description, applied medical determined that this event is not reportable as it was not patient related and did not cause or contribute to death or serious injury.There was no patient injury related to this complaint, and it was a surgeon observation.

• Brand Name: EPIX LAPAROSCOPIC GRASPER
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA ; AS
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20838179
• Report Number: 2027111-2024-00937
• Device Sequence Number: 3758340
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: C4130
• Was Device Available for Evaluation?: No
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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