MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN LLC TRUCLEAR SOFT TISSUE SHAVER MINI; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number REF72202536

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  Injury  

Event Description

Tru clear soft tissue shaver mini broke in two pieces inside the scope while the surgeon was using it.Both pieces were removed from the scope and accounted for.No visible injury noted to the pt.Fda safety report id# (b)(4).

• Brand Name: TRUCLEAR SOFT TISSUE SHAVER MINI
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MEDTRONIC / COVIDIEN LLC
• MDR Report Key: 9145241
• MDR Text Key: 161003334
• Report Number: MW5090134
• Device Sequence Number: 1
• Product Code: HIH
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: REF72202536
• Device Lot Number: 4906258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• 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: 33 YR
• Patient Weight: 68