MAUDE Adverse Event Report: TELEFLEX TELEFLEX MINIGRIP; MINIGRIP CLUTCH GRASPER

Model Number	PGCC300
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon is given the minigrip, practiced how to arm it and the grasping sensation.She arms the needle and inserts the device, once in the abdomen the arming button was released.As the jaws opened they noticed that there was a piece missing.The surgeon is sure that it didn't fall in the abdomen but broke during the arming of the tip.They took out the minigrip and did the procedure with a trocar and 5mm grasper.No add'l surgery was necessary, just an abdomen x-ray in which it was confirmed that the missing piece was not in the pt.The pt is fine and left the hospital the day after the surgery as in routine.(b)(4).

• Brand Name: TELEFLEX MINIGRIP
• Common Device Name: MINIGRIP CLUTCH GRASPER
• Manufacturer (Section D): TELEFLEX
• MDR Report Key: 6787545
• Report Number: MW5071501
• Device Sequence Number: 964835
• Product Code: GEI
• UDI-Device Identifier: 24026704582611
• UDI-Public: 24026704582611
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2017

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: 02/03/2018
• Device Model Number: PGCC300
• Device Catalogue Number: PGCC300
• Device Lot Number: GML-00112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2017
• Patient Sequence Number: 1