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

Model Number 7209383

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

Patient Problems Perforation (2001); Tissue Damage (2104); No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during transvaginal insertion under a hysteroscopy with the use of dilator, perforation occurred and penetrating into the abdominal cavity, the operation was changed to laparoscopic operation.The perforated site was repaired, and polypectomy was performed again under hysteroscope using competitor's device.The surgical time was extended by more than 30 min.There was tissue damage.The incision site was extended by less than 3 cm.It was also noted that there was difficulty in the insertion and had increase in size.

• 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: 9407312
• MDR Text Key: 169012836
• Report Number: 1282497-2019-00031
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521746732
• UDI-Public: 10884521746732
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209383
• Device Catalogue Number: 7209383
• Device Lot Number: 1547453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Date Device Manufactured: 04/29/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR