MAUDE Adverse Event Report: COOPER SURGICAL, INC FISHER CONE BIOPSY EXCISOR; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number 900-151

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  Injury  

Event Description

Patient was consented for a laparoscopic tubal litigation, removal of an iud and leep of the cervix.During the leep, the tips of the leep electrode came off the electrode into the patient¿s uterus.A hysterectomy was done to locate the tip of the electrode and it was retrieved.Fda safety report id # (b)(4).

• Brand Name: FISHER CONE BIOPSY EXCISOR
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COOPER SURGICAL, INC; trumbull CT 06611
• MDR Report Key: 9496499
• MDR Text Key: 172425693
• Report Number: MW5091773
• Device Sequence Number: 1
• Product Code: HGI
• UDI-Device Identifier: 20888937003714
• UDI-Public: 20888937003714
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2021
• Device Catalogue Number: 900-151
• Device Lot Number: 238680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 74