MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Name of procedure being performed: robotic laparoscopic rectopexy.Detailed description of event: the rep was not present during the case.During the case the assistant was moving the grasper up the sigmoid colon while the robot arm was moving down the sigmoid colon.During the course of this movement, the grasper jaws and a portion of the green shaft broke and fell into the patient.The entire device, including the portion that broke off, was removed from the patient and the case was completed with the other grasper already in use during the case.No harm to patient.Product is available for return.Additional information received via email on 13jul2021 from [name]: contact information for facility contact has been provided.Photos of the device have been provided.Patient status: no harm to patient.Type of intervention: used other grasper in the case to complete case.
Event or Problem Description
Name of procedure being performed: robotic laparoscopic rectopexy detailed description of event: the rep was not present during the case.During the case the assistant was moving the grasper up the sigmoid colon while the robot arm was moving down the sigmoid colon.During the course of this movement, the grasper jaws and a portion of the green shaft broke and fell into the patient.The entire device, including the portion that broke off, was removed from the patient and the case was completed with the other grasper already in use during the case.No harm to patient.Product is available for return.Additional information received via email on 13jul2021 from [name]: contact information for facility contact has been provided.Photos of the device have been provided.Patient status: no harm to patient.Type of intervention: used other grasper in the case to complete case.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the grasper jaws and a portion of the shaft had separated from the event unit.Based on the condition of the returned unit, it is likely that the fracture was caused by a large force that was applied to the device.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 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: 12278392
• Report Number: 2027111-2021-00591
• Device Sequence Number: 17329063
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)240329(30)01(10)1412627
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 03/29/2024
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1412627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI ROBOT.