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

Catalog Number	DC0235
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2024.Micro-tech got the further information regarding this incident.The dc0235, lot number:m210701598 was the expired clip that was used on the patient on (b)(6) 2024.The clip worked correctly and was controlling the bleeding.Based on the lot information provided by the customer, we confirm that the clip was expired.( valid for three years, from (b)(6) 2024 ) this event is not a product quality issue.According to the validity period of the clips and the clear description in the ifu.The first clear description of the preparation work in ifu is "check use by date.Do not use device if expired." we suggest the users should check the expiration date before use.Micro-tech will continue to monitor this event to ensure patient safety.
Event or Problem Description
The customer placed an expired dura clip into the patient.The clip worked correctly and was controlling the bleeding.

• Brand Name: DURACLIP
• 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
• Manufacturer (Section G): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 20890955
• Report Number: 3004837686-2024-00013
• Device Sequence Number: 13022454
• Product Code: PKL
• UDI-Device Identifier: 16932619740019
• UDI-Public: (01)16932619740019(17)240630(10)M210701598
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: 06/30/2024
• Device Catalogue Number: DC0235
• Device Lot Number: M210701598
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown