MAUDE Adverse Event Report: MICRO-TECH (NANJING) CO., LTD. LESIONHUNTER ROTATABLE NITINOL COLD SNARE; SNARE, SURGICAL

Lot Number M221218301

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

Event Type  Injury  

Event Description

Snare head broke off around polypectomy site.Surgeon was able to retrieve snare head from colon.No patient harm as a result of the malfunction.

• Brand Name: LESIONHUNTER ROTATABLE NITINOL COLD SNARE
• Type of Device: SNARE, SURGICAL
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD.
• MDR Report Key: 16911363
• MDR Text Key: 315112614
• Report Number: MW5117465
• Device Sequence Number: 1
• Product Code: GAE
• 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: 05/05/2023

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 Lot Number: M221218301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White