MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGICAL

Model Number C4120

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: ni.Event description: the event date is unknown.The following information/request was received via email from [name] on 9 june 2022: do you know if there have been many cers in the past for c4120 38cm grasper shaft for northern beaches hospital? they said they have had bad experience in the past with the tip falling off during a procedure.Is this a quality issue we had for this product in the past? additional information was received via email from [name] on 10 june 2022: you mention the following: 'they said they have had bad experience in the past with the tip falling off during a procedure.' do you know if they submitted a complaint for this event and a rough estimated date for it? unfortunately no i don¿t know if they submitted a complaint, i am trying to find that out and if it was a known quality issue in the past.I think it must have been for a previous iteration of the device if there is one? i¿ll ask around with some of the more tenured members to see if they remember anything.Intervention: ni.Patient status: ni.

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.

Event Description

Procedure performed: ni.Event description: the event date is unknown.The following information/request was received via email from [name] on 9 june 2022: do you know if there have been many cers in the past for c4120 38cm grasper shaft for [user facility]? they said they have had bad experience in the past with the tip falling off during a procedure.Is this a quality issue we had for this product in the past? additional information was received via email from [name] on 10 june 2022: unfortunately no i don¿t know if they submitted a complaint, i am trying to find that out and if it was a known quality issue in the past.I think it must have been for a previous iteration of the device if there is one? i¿ll ask around with some of the more tenured members to see if they remember anything.Intervention: ni.Patient status: ni.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGICAL
• 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: 14859763
• MDR Text Key: 303295567
• Report Number: 2027111-2022-00649
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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: C4120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 09/14/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1