MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG REMOVE DC CUTTER SET 12; ENDOSCOPIC ELECTROSURGICAL CLIP CUTTING SYSTEM

Catalog Number 400.02.01 S

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2023

Event Type  malfunction  

Event Description

During upper gi endoscopy to remove esophageal stent, one of the three prongs on the end of the "remove dc cutter set 12" broke off and was not retrievable in the procedure.No harm was determined and the patient will pass the small piece according to the provider.This is being reported voluntarily on the 3500 form anyway.

• Brand Name: REMOVE DC CUTTER SET 12
• Type of Device: ENDOSCOPIC ELECTROSURGICAL CLIP CUTTING SYSTEM
• Manufacturer (Section D): OVESCO ENDOSCOPY AG
• MDR Report Key: 17949565
• MDR Text Key: 326008323
• Report Number: MW5147001
• Device Sequence Number: 1
• Product Code: QAG
• 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: 10/10/2023

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 Catalogue Number: 400.02.01 S
• Device Lot Number: 843696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White