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

Model Number	7209383
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Tissue Damage (2104); No Code Available (3191)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9407312
• Report Number: 1282497-2019-00031
• Device Sequence Number: 17140514
• Product Code: HIH
• UDI-Device Identifier: 10884521746732
• UDI-Public: 10884521746732
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7209383
• Device Catalogue Number: 7209383
• Device Lot Number: 1547453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR