MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; NWV

Model Number	C4120
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: lap liver resection.Incident description: as using grasper in some point in the middle of the case, one of the latis pads fell off.It occurred when they were moving and manipulating tissue.As the doctor looked at the jaws, he noticed the pad had fully detached from the jaws.They were able to retrieve the pad.The product will not be returning as the hospital disposed the product.Type of intervention: na.Patient status: no patient injury.
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.However, a photo of the event unit confirmed that the latis pad had detached from the jaws of the event unit.In the absence of the subject device, it is difficult to determine the root cause of the event.Based on the photo that was provided from the complainant, it is possible that the device was subjected to excessive force during use.

• Brand Name: C4120, 38CM 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: 6679199
• Report Number: 2027111-2017-01895
• Device Sequence Number: 1973023
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)200111(30)01(10)1286193
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/11/2020
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Device Lot Number: 1286193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/17/2017
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other