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

Model Number CS2-21523231

Device Problem Break (1069)

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

Event Date 12/15/2022

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

It was reported that product was successfully used on larger polyp of same patient just prior to "breaking completely" when attempting removal of second polyp.All broken pieces were retrieved.No obvious harm to patient.Removal then required use of cautery.This is a follow-up to the hospital issued mdr and there was no death or serious injury.

Manufacturer Narrative

1.Description of adverse phenomena 1.1 the customer description: product was successfully used on larger polyp of same patient just prior to "breaking completely" when attempting removal of second polyp.1.2 external investigation 1.2.1 the size of the polyps during the surgery: 35mm polyp was removed unremarkably.The 20mm polyp removal was affected by the malfunctioning snare.1.2.2 the type of polyp during surger: sessile; granular lateral spreading 1.2.3 the specific location of the surgery: ascending colon 1.2.4 what is the patient's physical condition: post-op vital signs were adequate.The patient was discharged to phase ii care and then home on (b)(6) 2022, the same day as the procedure.Further summary from procedure report: a 20 mm polyp was found in the ascending colon.The polyp was sessile.A saline injection-lift technique using a cold snare was planned snare.After adequate lift, the polyp was ensnared, but the snare wires broke leaving the snare in the polyp base tissue.A forceps was used to remove the wire.A hot snare was then placed around the polyp base, and the polyp was resected with a hot snare.Resection and retrieval were complete.1.3 complaint specification: cs2-21523231, complaint batch number: m210331304, check the production record of this batch, a total of (b)(4) 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 according to the information fed back by customers, combined with the historical feedback and product structure, we conducted troubleshooting on the intended use, raw materials, production process, application instructions and storage.The specific investigation information is as follows: the cold snare is suitable for endoscopic removal of small polyps, pedicled polyps, pedicled polyps and tissues from the gastrointestinal tract.Analysis: the description of the intended use is clear and clear, and there will be no ambiguity when it is used to "remove small polyps, pedicled polyps, pedicled polyps and tissues from the gastrointestinal tract".In addition, from 2021 to december 2022, we sold 2.7217 million cold snares.According to statistics, the first occurrence of the fall of the ferrule is 3.67 * 10-7, with a very low probability of occurrence.Therefore, we can determine that the intended use of the cold snare can meet the clinical requirements.According to customer feedback a 35 mm polyp was removed with no apparent abnormalities.20 mm polyp removed compromised by malfunctioning snare.2.2 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.If riveting tooling fails, it will produce poor batch size, this process is completed by the supplier, iqc will randomly sample the raw materials at the time of incoming material, and the batch number of the original material of the loop corresponding to this batch is 20210310j04-i012 after inquiry, and the tensile test of this batch is ok.And from 2021 to december 2022, we sold 2.7217 million cold ferrules.According to statistics, the ferrule fell off for the first time, with a probability of 3.67 * 10-7, which is very low.Therefore, we can confirm that this customer complaint has nothing to do with raw materials, size, appearance, etc.2.3 production process according to the lot number provided by the customer, we checked the dhr.The loop assembly corresponding to the lot number of this finished product was qualified in the production process: riveting tension first and last inspection, ipqc sampling inspection, completion inspection and delivery inspection.Therefore, it was excluded that the riveting tool failure caused the loop detachment due to unqualified tension.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.The operating handle extends out of the ferrule and gently encircles 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 that the appropriate tissue has been trapped, and then gently pull the slider to remove.2.4.5.Repeat steps 3 and 4.Retract the snare prior to removing the instrument from the endoscope.Analysis: the manual explains the use method: "confirm that the appropriate tissue has been trapped, and then gently pull the slider to remove".The description is clear and unambiguous, so we can determine that this event has nothing to do with the use method 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 determine that this event has nothing to do with storage.3.Summary after checking the intended use, raw materials, production process, application instructions and storage of the cold snare wrapper, it is found that it meets the requirements of the standard, so the root cause of the fall of the cold snare, according to customer feedback a 35 mm polyp was removed with no apparent abnormalities.20 mm polyp removed compromised by malfunctioning snare.We suspect the cut polyp was too large causing the band to break.And 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: 16191912
• MDR Text Key: 307581439
• Report Number: 3004837686-2023-00001
• 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
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: CS2-21523231
• Device Catalogue Number: CS50061
• Device Lot Number: M210331304
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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 Age: 61 YR
• Patient Sex: Male