MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72204878

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the hystrectomy polypectomy and non-medtronic ablation, polypectomy was finished within 5 minutes.800ml fluid given and 600ml returned leaving deficit of 200ml.Performed the ablation and within the duration of 40 seconds, the patient's heart rate dropped from 62 beats per minute to 40 beats per minute.The doctor stopped the procedure for 30 seconds to have a drug that help balance the patient's heart rate administered to continue the procedure.The ablation started again for 15 seconds and the patient heart rate dropped to zero and the surgical technician was prompted to give chest compression.After 3-4 compression, the patient recovered the heart rate back at 72 bpm.The doctor introduced the hysteroscope back into the cavity to check for perforation and any additional indication for why this may have happened.No perforation and fluid loss stayed stable at 200ml.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10714650
• MDR Text Key: 212483748
• Report Number: 1282497-2020-00043
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521746633
• UDI-Public: 10884521746633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204878
• Device Catalogue Number: 72204878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1