MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. LESIONHUNTER(TM) ROTATABLE NITINOL COLD SNARE

Catalog Number CS2-21023231

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The products released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.However, the incident investigation is ongoing.A follow-up report will be filed following the completion of the incident investigation.

Event Description

On march 8, 2023.Micro-tech received a mdr report notice from fda.Mdr report #: mw5115232.It was reported that "micro-tech lesion hunter cold snare wire loop broke free from device during use.A 45 year old male scheduled for colonoscopy undergoing routine polypectomy.During insertion of cold snare, after opening wire loop it broke free from device.(micro-tech lesion hunter cold snare, lot#: m220410302, exp:4/9/2024, ref#: (b)(4) snare was removed from scope and wire loop retrieved by endoscopist without complication.Polyp removed and procedure completed without further incident.There was no harm to the patient".

Manufacturer Narrative

1.Description of adverse event: it was reported that "micro-tech lesion hunter cold snare wire loop broke free from device during use.A 45 year old male scheduled for colonoscopy undergoing routine polypectomy.During insertion of cold snare, after opening wire loop it broke free from device.(micro-tech lesion hunter cold snare, lot# m220410302, exp:4/9/2024, ref# (b)(4)) snare was removed from scope and wire loop retrieved by endoscopist without complication.Polyp removed and procedure completed without further incident.There was no harm to the patient".2.According to complaint feedback information, combined with historical customer complaint and product structure, we investigate the intended use, raw materials, production process, applicable instructions and storage, and the specific investigation information is as follows: 2.1 intended use: the cold snare is indicated for use endoscopically for the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.Analysis: the description of intended use is clear and clear, and there will be no ambiguity in "removing small polyps, non-stultiform polyps, and stultiform polyps and tissues from gastrointestinal tract".In addition, from 2021 to december 2022, we sold a total of (b)(4) cold snare devices.According to statistics, this type of complaint has occurred for the second time, with a probability of 7.3*10-7.The probability of occurrence is very low, so we can be sure that the intended use of cold snare can meet clinical requirements.2.2 raw material: raw materials: cold snare consists of loop, outer tube, plunger rod, sliding block, etc.Raw materials shall be put into storage after their materials, appearance and dimension are qualified.Iqc will randomly draw the raw materials at the time of incoming materials.After inquiry, the batch number of original materials of loop corresponding to this batch is 20220218j07-i004 & 20220223j07-i006 & 20220303j07-i006 & 20220315j22-i007.Four batches of tensile force test are ok.2.3 production process: according to the batch number provided by the customer, we checked dhr and found that the batch number of this batch of finished products corresponded to 4 batches of snare assembly.The production process: the first and last inspection of riveting tension, ipqc sampling inspection, completion inspection and factory inspection were all qualified.Therefore, the failure of riveting tooling caused by unqualified tension caused by snare falling off was excluded.2.4 instructions for use: 2.4.1.Retract the handle of the snare and confirm that the snare loop is fully retracted into the catheter prior to inserting the catheter into the endoscope.2.4.2.Slowly advance the catheter through the endoscope channel until the tip appears in the endoscopic view and the lesion is clearly identified and targeted.2.4.3.Operate the hande to extend the snare loop and gently snare the target tissue; note: the snare loop can be rotated if desired by holding the outer sheath assembly androtating the handle.2.4.4.Confirm appropriate tissue is captured and proceed to resect by gently pulling the slider.2.4.5.Repeat steps 3&4 asreguired.Retract the snare prior to removing the instrument from the endoscope.Analysis: the instruction manual clarifies the method of use: " operate the hande to extend the snare loop and gently snare the target tissue ".The description is clear and clear, and there will be no ambiguity, so we can confirm this customer complaint it has nothing to do with the method of use described in the manual.2.5 storage: we have specific requirements for the storage of cold snare products: the product should be stored in a cool, dry, clean, well-ventilated, non-corrosive gas environment.Do not expose the package to organic solvent, ionizing radiation or ultraviolet radiation.Analysis: the validity period of the cold snare was confirmed in detail in the design and development stage, and the cold snare was confirmed to be safe and effective in the validity period.More detailed storage conditions are also detailed in the manual.Therefore, we can confirm that this cold snare customer complaint has nothing to do with storage.3.Summary: after checking the expected use, raw materials, production process, application instructions and storage of the cold snare, they all meet the standard requirements, and no bad pictures and samples have been received, and no more relevant information can be further analyzed.Therefore, the root cause of the cold snare fracture has not been found.We will continue to pay attention to it.

• Brand Name: LESIONHUNTER(TM) ROTATABLE NITINOL COLD SNARE
• Type of Device: COLD SNARE
• 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: 16580406
• MDR Text Key: 312290840
• Report Number: 3004837686-2023-00002
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2024
• Device Catalogue Number: CS2-21023231
• Device Lot Number: M220410302
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1