MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM LATIS GRASPER CART, 10/BX; LAPAROCOPIC ACESSORIES, GYNECOLOGIC

Model Number C4120

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure: toupet fundoplication.The rep was present for the case.Surgeon was using 2 graspers during the case.The handle was sticking and not opening & closing smoothly throughout the case.The surgeon was grasping the stomach and went to release the handle.He had a hard time getting the jaws to open and they were stuck inside the trocar within the abdomen.He kept manipulating and squeezing the handle to get it to release and remove from the trocar.Once the grasper was removed from the trocar, they could not get it to close.Opened a c4130 grasper to use alongside the 2nd c4120 grasper being used to complete the case.There was no patient injury.There are no photos available.The device is available to be returned.Patient status: no patient injury.Type of intervention: opened another grasper to complete case.

Event Description

Procedure performed: toupet fundoplication.Complaint (b)(4) - will address the c4120 lot 1382206 (jaws & handle sticking/not functioning).Complaint (b)(4) - will address the c4120 lot unknown (broken hinge).The rep.Was present for the case.Surgeon was using 2 graspers during the case.The handle was sticking and not opening & closing smoothly throughout the case.The surgeon was grasping the stomach and went to release the handle.He had a hard time getting the jaws to open and they were stuck inside the trocar within the abdomen.He kept manipulating and squeezing the handle to get it to release and remove from the trocar.Once the grasper was removed from the trocar, they could not get it to close.Opened a c4130 grasper to use alongside the 2nd c4120 grasper being used to complete the case.There was no patient injury.There are no photos available.The device is available to be returned.Intervention: opened another grasper to complete case.Patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult 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.

• Brand Name: C4120, 38CM LATIS GRASPER CART, 10/BX
• Type of Device: LAPAROCOPIC ACESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10297896
• MDR Text Key: 199938938
• Report Number: 2027111-2020-00508
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)230306(30)01(10)1382206
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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 Expiration Date: 03/06/2023
• Device Model Number: C4120
• Device Catalogue Number: 101473343
• Device Lot Number: 1382206
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1