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

Model Number	PGAC300 MINIGRIP ALLIGATOR GRASPER
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial submission was erroneously submitted as a 5 day report and the firm was not required to initiate action to prevent an unreasonable risk of substantial harm.
Event or Problem Description
It was reported that during the suprarenal laparoscopic surgery suprarenal performed by dr.(b)(6), the opening was perfect, without any issue.The incident happened when the retraction of the adipose broke.Additional info.Device used per ifu: yes.Harm or injury to the patient? no.Did any broken part remain inside the patient? no.If so how were they removed? the piece was removed using another grasper without any difficultly.
Additional Manufacturer Narrative
The initial submission was erroneously submitted as a 5 day report and the firm was not required to initiate action to prevent an unreasonable risk of substantial harm.
Event or Problem Description
It was reported that during the suprarenal laparoscopic surgery suprarenal performed by dr.(b)(6), the opening was perfect, without any issue.The incident happened when the retraction of the adipose broke.Additional info.Device used per ifu: yes.Harm or injury to the patient? no.Did any broken part remain inside the patient? no.If so how were they removed? the piece was removed using another grasper without any difficultly.

• 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: 7457951
• Report Number: 3002770040-2018-12349
• Device Sequence Number: 18891856
• 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,Followup
• Report Date (Section B): 04/23/2018

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: 09/28/2018
• Device Model Number: PGAC300 MINIGRIP ALLIGATOR GRASPER
• Device Catalogue Number: PGAC300
• Device Lot Number: GML-00156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1