MAUDE Adverse Event Report: ENCISION INC. INSERT, CURVED SCISSOR, 3/4"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ES0002
Medical Device Problem Codes	Material Fragmentation (1261); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a hysterectomy procedure, the surgeon was attempting to cut a 0 v-loc suture with an encision es0002 reusable scissor insert.The suture was used to close the vaginal cuff.The scissor insert slipped on the first attempt to cut suture.On the second attempt to cut suture, the scissor broke.The force of the cut attempt, which led to the breakage, caused the scissor blades to shoot to the left, making the insert unusable.The scissor blades and housing remained attached to the handle, into which the scissor is threaded.However, the rod pin likely split and fell out of the housing into the patient.The surgeon and the technician heard an audible rattle during the suction operation.An ap and lateral x-ray was taken following the procedure.No foreign objects were found in the patient.

• Brand Name: INSERT, CURVED SCISSOR, 3/4"
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ENCISION INC.; 6797 winchester circle; boulder CO 80301
• MDR Report Key: 12584734
• Report Number: 1722040-2021-00002
• Device Sequence Number: 4344205
• Product Code: GEI
• UDI-Device Identifier: 10815288010996
• UDI-Public: 10815288010996
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: ES0002
• Device Catalogue Number: ES0002
• Device Lot Number: AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention