MAUDE Adverse Event Report: TRANSMED (CHINA) CO LTD DURACLIP HEMOCLIP 16MM

Catalog Number DC0235W

Device Problems Break (1069); Fracture (1260)

Patient Problem Hyperemia (1904)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

Corrections: this complaint was previously filed under 1320894-2019-00030 as the manufacturer.It has since been determined that transmed is the responsible party, we are the importer.(b)(4).Distributor narrative; the manufacturer, transmed (b)(4) co.Ltd, is responsible for performing evaluation, investigation and any remedial actions related to this reported device issue per agreement with (b)(4) corporation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This is a voluntary distributor report: the (b)(4) representative reported that during an endoscopic mucosal resection (emr) the doctor placed 5 clips on the antral bulb defect using the dco235w, 16mm duraclip applier.There were no reported issues with the initial surgery; however, the patient returned a few days later with bleeding because a few of the clips fell off.The patient was hospitalized.Further attempts were made to find out what intervention were done; however, no other information was received other than the patient's status is good.This report is being raised based on patient injury.

• Brand Name: DURACLIP HEMOCLIP 16MM
• Type of Device: HEMOCLIP
• Manufacturer (Section D): TRANSMED (CHINA) CO LTD; no 10 gaoke third road; nanjing national hi-tech ind.; nanjing, jiangsu 21003 2; CH 210032
• MDR Report Key: 8469606
• MDR Text Key: 140486050
• Report Number: 3007216334-2019-00097
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2019,04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DC0235W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other