MAUDE Adverse Event Report: ETHICON INC. GYNECARE VERSAPOINT; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	00468
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Versapoint spring tip cautery was being used by doctor.During use doctor said that he noticed the tip no longer looked like a spring, but a ball at the end of the versapoint spring cautery.

• Brand Name: GYNECARE VERSAPOINT
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; route 22 west; po box 151; somerville NJ 08876
• MDR Report Key: 8784478
• Report Number: 8784478
• Device Sequence Number: 11179648
• Product Code: HIH
• UDI-Device Identifier: 10705031000797
• UDI-Public: (01)10705031000797
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019
• Report Date (Section F): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 00468
• Device Catalogue Number: 00468
• Device Lot Number: UGY1807082
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 230
• Date Report Sent to FDA: 07/11/2019