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

Model Number	C4120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: paraesophageal hernia repair.The rep was not present for the case.In the middle of the case, the surgeon went to squeeze the handle and the hinge broke and came out of the shaft.It is unknown what type of tissue was being grasped when the breakage occurred.A new grasper was opened to complete the case.There was no patient injury.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 returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed that the hinge of the device broke.Engineering disassembled the unit and observed that the internal components of the device were damaged.Based on the condition of the returned unit, the internal components of the device were damaged by the force applied to the jaws during use.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: paraesophageal hernia repair.The rep was not present for the case.In the middle of the case, the surgeon went to squeeze the handle and the hinge broke and came out of the shaft.It is unknown what type of tissue was being grasped when the breakage occurred.A new grasper was opened to complete the case.There was no patient injury.The device is available to be returned.Additional information received via email on 02jul2020 from [name], applied medical account mgr " it happened while he was grasping the stomach".Photo provided.Intervention: opened another grasper to complete case.Patient status: no patient injury.

• Brand Name: C4120, 38CM LATIS GRASPER CART, 10/BX
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10221510
• Report Number: 2027111-2020-00493
• Device Sequence Number: 16745194
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)230303(30)01(10)1381848
• 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): 09/24/2020

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: 03/03/2023
• Device Model Number: C4120
• Device Catalogue Number: 101473343
• Device Lot Number: 1381848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1