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

Model Number C4120

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

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 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.

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
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 6679199
• MDR Text Key: 78785031
• Report Number: 2027111-2017-01895
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)200111(30)01(10)1286193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 06/27/2017
• Supplement Dates FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other