MAUDE Adverse Event Report: MICRO-TECH (NAN JING) CO., LTD. SURE CLIP REPOSITIONABLE HEMOSTASIS CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Catalog Number ROC-C-26-235-C-N

Device Problem Mechanics Altered (2984)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

During egd/poem procedure in gi lab, clip was placed down the working channel into the patient's esophagus.Attempted to open clip, unsuccessful.Clip taken out of patient/working channel and attempt made to open clip unsuccessful.Other subsequent clips from same box/lot number worked with no issues.No harm to patient.Fda safety report id# (b)(4).

• Brand Name: SURE CLIP REPOSITIONABLE HEMOSTASIS CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): MICRO-TECH (NAN JING) CO., LTD.
• MDR Report Key: 14756543
• MDR Text Key: 294572433
• Report Number: MW5110401
• Device Sequence Number: 1
• Product Code: PKL
• 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: 06/15/2022

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: 10/02/2023
• Device Catalogue Number: ROC-C-26-235-C-N
• Device Lot Number: M201003239
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female