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

Model Number C4130

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

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: ni.Event description: complaint created based on feedback portal submission #2953.Submitted 07feb2022.User complains graspers are dangerous since they have minimal surface contact.The minimal surface contact of the grasper either "makes the grabbing of tissue ineffective, as the instrument comes loose, or traumatic for the tissue".They report the graspers cause gastric tears.Additional information received via email on 15feb2022 from [name], applied medical account manager: "i do know it would¿ve happened at either [facility] or [facility].He did mention that he was not happy when we changed the extended a-trac pad that used to be in place to the much smaller pad." additional information received via phone on 17feb2022 from [name], applied medical account manager: the surgeon complaint is in regards to the reposable grasper.The customer receives c4120 reposable grasper cartridges.The surgeon does not use the disposable grasper (c4130).The rep has not been informed of any saved product but will check with the facility to confirm.Additional information received via email on 17feb2022 from [name], applied medical account manager: "dr.[name] does use the reposable grasper.His chief complaint is the change in the length of the a-traumatic pad.Evidently at one time the pad was longer than it is now and because of this it has caused the issue he stated in is complaint." the issues occurred before the rep first came to the facility.The rep's first meeting with the surgeon was on (b)(6) 2021.Intervention: ni.Patient status: gastric tears occurred with use.

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: ni.Event description: complaint created based on feedback portal submission #2953.Submitted 07feb2022.User complains graspers are dangerous since they have minimal surface contact.The minimal surface contact of the grasper either "makes the grabbing of tissue ineffective, as the instrument comes loose, or traumatic for the tissue".They report the graspers cause gastric tears.Additional information received via email on 15feb2022 from [name], applied medical account manager: "i do know it would¿ve happened at either [facility] or [facility].He did mention that he was not happy when we changed the extended a-trac pad that used to be in place to the much smaller pad." additional information received via phone on 17feb2022 from [name], applied medical account manager: the surgeon complaint is in regards to the reposable grasper.The customer receives c4120 reposable grasper cartridges.The surgeon does not use the disposable grasper (c4130).The rep has not been informed of any saved product but will check with the facility to confirm.Additional information received via email on 17feb2022 from [name], applied medical account manager: "dr.[name] does use the reposable grasper.His chief complaint is the change in the length of the a-traumatic pad.Evidently at one time the pad was longer than it is now and because of this it has caused the issue he stated in is complaint." the issues occurred before the rep first came to the facility.The rep's first meeting with the surgeon was on (b)(6) 2021.Intervention: ni.Patient status: gastric tears occurred with use.

Event Description

Procedure performed: hiatal hernia repair.Event description: complaint created based on feedback portal submission #2953.Submitted 07feb2022.User complains graspers are dangerous since they have minimal surface contact.The minimal surface contact of the grasper either "makes the grabbing of tissue ineffective, as the instrument comes loose, or traumatic for the tissue".They report the graspers cause gastric tears.Additional information received via email on 15feb2022 from [name], applied medical account manager: "i do know it would¿ve happened at either [facility] or [facility] surgery center.He did mention that he was not happy when we changed the extended a-trac pad that used to be in place to the much smaller pad." additional information received via phone on 17feb2022 from [name], applied medical account manager: the surgeon complaint is in regards to the reposable grasper.The customer receives c4120 reposable grasper cartridges.The surgeon does not use the disposable grasper (c4130).The rep has not been informed of any saved product but will check with the facility to confirm.Additional information received via email on 17feb2022 from [name], applied medical account manager.: "dr.[name] does use the reposable grasper.His chief complaint is the change in the length of the a-traumatic pad.Evidently at one time the pad was longer than it is now and because of this it has caused the issue he stated in is complaint." the issues occurred before the rep first came to the facility.The rep's first meeting with the surgeon was on 04oct2021.Additional information received via email on 12feb2022 from dr.[name], [user facility] surgeon: the product issue occurred at [user facility] multiple times on various dates.The different lot numbers of the affected devices are unknown.Procedure performed was hiatal hernia repair and the issue occurred consistently during one maneuver: grabbing the front of the stomach to keep it down while mobilizing the sac.In 90% of cases, the graspers would either not hold the tissue, let go of the tissue, require regrabbing of the tissue, or cause at least a serosal tear.The tears that occurred on the stomach did not require any intervention most of the time.There were a couple of instances where one stitch was used to bring the tissue back together.No patient injuries occurred.Additional information received via email on 25feb2022 from dr.[name], [user facility] surgeon: the multiple grasper events that occurred at [user facility] have never been reported.Intervention: the tears that occurred on the stomach did not require any intervention most of the time.There were a couple of instances where one stitch was used to bring the tissue back together.Patient status: no patient injuries occurred.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: the patient status, procedure performed and intervention methods within section b5 have been updated based on additional information received from the user facility.Section h1 is updated to "malfunction" from "serious injury", noted in the initial report (mw#2027111-2022-00389), based on additional received from the user facility, which confirmed that a serious injury did not occur.

• 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: 13560930
• MDR Text Key: 286021265
• Report Number: 2027111-2022-00389
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other