MAUDE Adverse Event Report: MICRO-TECH (NANJING) CO., LTD. DURACLIP HEMOCLIP, 235CM, 16MM; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	DC0235W
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed as a voluntary distributor report.The manufacturer, micro tech ((b)(4)), co.Ltd., is responsible for performing the evaluation, investigation and any remedial actions related to this reported device issue.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Voluntary distributor report.The customer reported that the device, dc0235w, duraclip hemoclip, 235cm, 16mm was being used during a polypectomy on (b)(6) 2020 when it was discovered that "tip fell off in scope during surgery".After further assessment questioning, it was found that the fragment fell into the patient and was retrieved.The procedure was completed without a delay.There was no report of injury, medical intervention or hospitalization for the patient due to this event.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: DURACLIP HEMOCLIP, 235CM, 16MM
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD.; no. 10 gaoke third road; nanjing national hi-tech zone; nanjing, 21003 2; CH 210032
• MDR Report Key: 11202473
• Report Number: 3007216334-2021-00049
• Device Sequence Number: 16711873
• Product Code: PKL
• UDI-Device Identifier: 16932619740033
• UDI-Public: (01)16932619740033(17)230824(10)M200825231
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2021
• Report Date (Section F): 01/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: DC0235W
• Device Catalogue Number: DC0235W
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/29/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/20/2021