MAUDE Adverse Event Report: ENDOPLUS ENDOPLUS ATRAUMATIC GRASPER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Atraumatic grasper broke inside patient during surgery, no harm to patient.

• Brand Name: ENDOPLUS ATRAUMATIC GRASPER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ENDOPLUS; 750 tower road; suite a; mundelein IL 60060
• MDR Report Key: 18094337
• Report Number: MW5147923
• Device Sequence Number: 7710250
• Product Code: GEI
• UDI-Device Identifier: 00817401020427
• UDI-Public: (01)00817401020427(10)1121
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White