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

Model Number CS50060

Device Problem Break (1069)

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

Event Date 07/18/2023

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 08/23/2023, micro-tech received a mdr report notification from fda.Mdr report #: mwmw5119920.It was reported that "while using the microtech lesionhunter rotatable nitinol cold snare, snare broke while inside the patient and needed to be retrieved with another device.This is the second occurrence of this happening at one of our facilities in the last 2 weeks.Product lot numbers are the same.M220403301.Device id cs2-21523231.There was no harm to either patient.".

Manufacturer Narrative

1.Description of incident.While using the micro-tech lesionhunter rotatable nitinol cold snare, snare broke while inside the patient and needed to be retrieved with another device.This is the second occurrence of this happening at one of our facilities in the last 2 weeks.There was no harm to either patient.Complaint specification: (b)(4), complaint batch number: m220403301, check the production record of this batch, a total of 1400 pcs were produced in this batch, and the products put in storage and sold are all qualified products.2.Cause analysis.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, nonstultiform polyps, and stultiform polyps and tissues from gastrointestinal tract".In addition, from january 2020 to july 2023, we sold about a total of (b)(4) cold snare devices.According to statistics, this type of complaint has occurred for the 5th time, with a probability of 1.4*10-6.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.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 20220226j17-i008 & 20220308j05-i011 & 20220323j22-i012.Three batches of tensile force test are ok.2.3 production process.According to the lot number provided by the customer, we checked the dhr.The lot number of this batch of finished products corresponds to 3 batches of loop assemblies.The production process: rivet tension first and last inspection, ipqc sampling inspection, completion inspection and delivery inspection were all qualified.Therefore, it was excluded that the rivet tension failure caused the loop detachment.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 and rotating 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.Retract the snare prior to removing the instrument from the endoscope.Analysis: the ifu 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 complaint has nothing to do with the method of use described in the ifu.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 cold snare was validated for the shelf life in detail during the design and development stage, which confirmed that the cold snare is safe and effective during the shelf life.More detailed storage conditions are also described in the instructions.Therefore, we can determine that this cold snare complaint is not related to storage.Summary: after investigating the intended use, raw materials, production process, applicable instructions and storage of the cold snare, all met the requirements of the standards, no defective pictures and samples were received, no more relevant information was available, and no further analysis was possible.Therefore, no root cause of the cold snare breakage was found, and we will pay continuous 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: 17601754
• MDR Text Key: 321715297
• Report Number: 3004837686-2023-00007
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/02/2024
• Device Model Number: CS50060
• Device Catalogue Number: CS2-215232321
• Device Lot Number: M220403301
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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
• Patient Outcome(s): Other