MAUDE Adverse Event Report: AESCULAP; TONSIL SNARE

Device Problems Use of Device Problem (1670); Misfire (2532); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 06/29/2016

Event Type  malfunction  

Event Description

A new snare gun was used in the bilateral tonsillectomy procedure that was scheduled.Per surgeon, the snare gun misfired and the snare wire used "sheard" surrounding tissue of the tonsils, causing additional bleeding.Surgeon used additional cautery to cauterize injured vessels.This prolonged the procedure time, thus prolonging anesthesia time.After the event in the operating room: aesculap sent the guns to their quality control department.Aesculap's qc sent them to (b)(4).Aesculap informed us that our original guns will be quarantined for a year.Aesculap sent us two new guns to replace the faulty guns.Aesculap claims the guns were not working correctly because we were using bausch & lomb wire.Md agreed to trial the aesculap guns with aesculap snare wires.Aesculap guns again didn't work correctly with the aesculap.

• Type of Device: TONSIL SNARE
• Manufacturer (Section D): AESCULAP; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 5839399
• MDR Text Key: 50914513
• Report Number: 5839399
• Device Sequence Number: 1
• Product Code: KBZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2016
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR