MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4121, 45CM GRASPER REPOS CART, 10/BX; NWV

Model Number	C4121
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: left robotic colectomy lower anterior resection at the end of the procedure, two plastic parts came off the end of the grasper and were found in the patient.It was the rubber inserts came off.Retrieved from the patient and there was no harm.Additional information was received via telephone on 08mar2019 from applied medical health system spec: the device was used on bowel using a robot and needle driver.The procedure was left robotic colectomy lower anterior resection.The patient is (b)(6) male.This was the only information available.Patient status: fine.Type of intervention: retrieved from the patient and there was no harm.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of pad detachment.The jaw had remnants of adhesive and fragments of the pad.Based on the condition of the returned unit, it is likely that the pad detachment resulted from a shear force that was applied to the pad 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: left robotic colectomy lower anterior resection at the end of the procedure, two plastic parts came off the end of the grasper and were found in the patient.It was the rubber inserts came off.Retrieved from the patient and there was no harm.Additional information was received via telephone on 08mar2019 from applied medical health system spec: the device was used on bowel using a robot and needle driver.The procedure was left robotic colectomy lower anterior resection.The patient is 77 year old 187 pound male.This was the only information available.Patient status: fine type of intervention: retrieved from the patient and there was no harm.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 10/BX
• Common Device Name: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8481087
• Report Number: 2027111-2019-00404
• Device Sequence Number: 1664255
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)211126(30)01(10)1341952
• 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): 06/06/2019

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: 11/26/2021
• Device Model Number: C4121
• Device Catalogue Number: 101472473
• Device Lot Number: 1341952
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 06/06/2019
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 85