MAUDE Adverse Event Report: ENCISION INC. ENCISION ES0537 WAVE GRASPER, 35CM; LAPAROSCOPIC GRASPER

Model Number	ES0537
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial review of returned device showed grasper linkage component broke, preventing instrument function.Inspection under magnification not do identify any loose or absent material or components.
Event or Problem Description
Customer reported during laparoscopic cholecystectomy that incision es0537 wave grasper insert broke at the base of the jaw near the hinge.Customer reported no serious injury or medical intervention required.Customer reported no risk of serious injury or death if the event reoccurred.

• Brand Name: ENCISION ES0537 WAVE GRASPER, 35CM
• Common Device Name: LAPAROSCOPIC GRASPER
• Manufacturer (Section D): ENCISION INC.; 6797 winchester cir; boulder CO 80301
• MDR Report Key: 9195086
• Report Number: 1722040-2019-00001
• Device Sequence Number: 13993067
• Product Code: GEI
• UDI-Device Identifier: 10815288011733
• UDI-Public: 10815288011733
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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 Model Number: ES0537
• Device Catalogue Number: ES0537
• Device Lot Number: YHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 89