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

Model Number	C4120
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: LAPAROCOPIC ACESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10297896
• Report Number: 2027111-2020-00508
• Device Sequence Number: 3065243
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)230306(30)01(10)1382206
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1