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

Model Number	DC0235W
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has stated that there are no devices being returned for evaluation.However, the incident investigation is ongoing.A follow-up report will be filed following the completion of the incident investigation.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Based on the customer complaint sample was not returned, we combine historical customer complaint information, we found that after the product was released, the pull hook was broken by force.According to the defective picture provided, we analyzed that when the pull hook opening is on the side, when the force is applied, the pull hook starts to move downward.The top of the pull hook is stressed, it is detached from the pin roll, and the opening is pulled from the side to the top.It separated from the clip assembly.During the clip release process, the head of pull hook has a large deformation, during the downward movement of the pull hook, there is a risk of metal chips falling after the top is stressed.The pull hook of the product breaks down and appears to be damaged.After evaluation, the patient will not be injured, and the fallen metal scrap will be discharged with the human body.This risk is acceptable through risk analysis.In order to improve the quality of our products, we will change the slotting from the side to the middle.When the pull hook is stressed, it starts to move downwards.When the top is stressed, the amount of deformation is dispersed.As the force increases, the pull hook can disengage from the pin roll before reaching the deformation limit.After the new pull hook is stressed, only the opening distance of the front end circle changes, and there is no break point around the open circle, so the pull hook can be prevented from being broken into the human body by force.

• 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, indu; nanjing, jiangsu 21003 2; CH 210032
• MDR Report Key: 9216704
• Report Number: 3004837686-2019-00005
• Device Sequence Number: 448564
• 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
• PMA/510(K) Number: K161463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem 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
• Initial Date Received by Manufacturer: 09/28/2019
• Supplement Date Received by Manufacturer: 09/28/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/09/2019
• 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