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

Model Number C4120

Device Problem Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

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 Description

Name of procedure being performed: ni.Detailed description of event: complaint created based on feedback portal submission (b)(4).Submitted 14oct2021.We met with dr.[name] to perform formative evaluation testing on the mim prototype graspers.Prior to performing testing, dr.[name] stated that he used our graspers years ago, and used them for a long time (over 10 years).He then stated that he stopped using them due to the tears and indentations they would cause on the delicate tissues he worked with.Dr.[name] then proceeded to state that he learned how to work with the graspers so they wouldn't tear tissue as much, but in the end decided to pull away from using our graspers because of this issue.He believed that this issue was due to the pad size of the graspers, in that the amount of surface area the pads would grab onto in relation to the force being applied, would cause the tearing and indentations.This was not a specific instance, but rather an observation dr.[name] made over the time of using our direct drive latis graspers.Product not available for return.Patient status: no patient injury or illness was reported within the description of the complaint event.Type of intervention: ni.

Event Description

Name of procedure being performed: ni.Detailed description of event: complaint created based on feedback portal submission # 2578.Submitted 14oct2021.We met with dr.[name] to perform formative evaluation testing on the mim prototype graspers.Prior to performing testing, dr.[name] stated that he used our graspers years ago, and used them for a long time (over 10 years).He then stated that he stopped using them due to the tears and indentations they would cause on the delicate tissues he worked with.Dr.[name] then proceeded to state that he learned how to work with the graspers so they wouldn't tear tissue as much, but in the end decided to pull away from using our graspers because of this issue.He believed that this issue was due to the pad size of the graspers, in that the amount of surface area the pads would grab onto in relation to the force being applied, would cause the tearing and indentations.This was not a specific instance, but rather an observation dr.[name] made over the time of using our direct drive latis graspers.Product not available for return.Patient status: no patient injury or illness was reported within the description of the complaint event.Type of intervention: 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 harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: section g3 has been updated with the correct date.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 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: 12801132
• MDR Text Key: 283513542
• Report Number: 2027111-2021-00716
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 01/18/2022
• 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