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	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being filed as a voluntary distributor report.The manufacturer, micro-tech (b)(4) is responsible for performing the evaluation, investigation and any remedial actions related to this reported device issue.
Event or Problem Description
Voluntary distributor report.On behalf of the customer, the conmed sales rep reported an issue with the dc0235w, duraclip hemoclip, lot # m190622231 that occurred (b)(6) 2019 during a colonoscopy at (b)(6).It was reported that the physician deployed a 16mm duraclip and after deployment a metal fragment was found in the patients colon.The fragment is believed to be from the clip or device driver.The fragment was maybe a millimeter.They did not remove the fragment.There were no issues with the clip pre-procedure.This report is being raised on the basis of injury as there was fragmentation, that may have been from the applier, that was not removed from the patient at the time of surgery.

• 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 h-tech zone; nanjing, 21003 2; CH 210032
• MDR Report Key: 9145088
• Report Number: 3007216334-2019-00349
• Device Sequence Number: 2623471
• Product Code: PKL
• UDI-Device Identifier: 16932619740033
• UDI-Public: (01)16932619740033(17)220621(10)M190622231
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/02/2019
• Report Date (Section F): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: DC0235W
• Device Catalogue Number: DC0235W
• Device Lot Number: M190622231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 10/02/2019