MAUDE Adverse Event Report: GRACE MANUFACTURING INC. PGAC300 MINIGRIP ALLIGATOR GRASPER

Model Number	PGAC300 MINIGRIP ALLIGATOR GRASPER
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was using in a case this morning.He moved the ratchet knob up to the "on" position to lock onto a specimen.When he wanted to reposition his grasp, he moved the ratchet knob into the "off" position and then tried to open the jaws of the applier by moving the black handle, but the jaws did not release.I told him to squeeze the handle back a little bit then allows the handle to kind of unhinge and then it will spring open.He pulled the handle back a couple times, but the jaws would not open.He pulled the handle forward and luckily the jaws opened, but it made a loud popping noise and the handle disengaged from controlling the jaws.He pulled the device out of the patient's abdomen and opened and closed the handle a couple times.The jaws did not open and close as he was doing this.There is a rattling noise coming from inside of the body of the handle indicating that something internally broke.

• Brand Name: PGAC300 MINIGRIP ALLIGATOR GRASPER
• Common Device Name: ALLIGATOR GRASPER
• Manufacturer (Section D): GRACE MANUFACTURING INC.; 614 sr 247; russellville AR 72802
• MDR Report Key: 7530279
• Report Number: 3002770040-2018-12350
• Device Sequence Number: 1704270
• Product Code: GEI
• UDI-Device Identifier: 14026704582607
• UDI-Public: 14026704582607
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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: 09/30/2018
• Device Model Number: PGAC300 MINIGRIP ALLIGATOR GRASPER
• Device Catalogue Number: PGAC300
• Device Lot Number: GML-00161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1