MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. COLD SNARE; SNARE, SURGICAL

Catalog Number CS3-11523230

Device Problems Unexpected Therapeutic Results (1631); Mechanics Altered (2984)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/14/2022

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 snare got stuck on polyp, they had to cut the end of the snare and sent him to surgery.

Manufacturer Narrative

1.Description of adverse event: snare got stuck on polyp, they had to cut the end of the snare and sent him to surgery.Complaint specification: (b)(4), lot number: m190524302, check the production record of this batch, this batch produced a total of (b)(4), and the products sold are all qualified products.At the same time, according to the historical customer complaints, this batch has not received any similar customer complaints before.2.External investigation: through communication with the customer, the patient is 65 years old, the size of the polyp: a 20 mm pedunculated polyp, no pictures and defective products available, and no more clinical information provided.3.Cause analysis: 3.1 intended use: 3.1.1cold snare is intended to be used without eletctro-cantery in the gastrointestinal tract for the endoscopic resection of diminutive polyps (less than or equal to 9mm) 3.1.2single or multiple polyps in digestive tract, the diameter should generally being less than or equal to 9 mm, the number of the multiple polyps being less than or equal to30.Analysis: the description of the intended use is clear.It is used for "single or multiple polyps in the digestive tract, and the diameter should generally be less than or equal to 9mm;" there is no ambiguity.According to the feedback from customers, the diameter of the polyp is 20mm, which exceeds 9mm, so we suspect the possible reason is that the polyp obtained is too large, so we recommend that the client use the appropriate equipment to complete the operation.3.2 structure design: this cold snare consists of a loop assembly, outer sheath assembly, core rod, a slider and sealing cap.Analysis: the working principle of the cold snare: the cold snare is used with the endoscope, and can pass through the endoscope hole with a diameter of 2.8mm and above.Operate the handle of the cold snare to retract the ferrule into the outer tube, and the cold snare enters the digestive tract through the endoscope channel hole.Operate the handle assembly to extend the collar and gently tighten the polyp to be removed.The loop is retracted and the polyp is removed.Re-operate the handle to retract the ferrule into the outer tube, pull out the cold snare, and repeat the above steps if necessary.Since 2020, we have sold a total of (b)(4) products.According to statistics, this type of customer complaint is the second occurrence.The probability of occurrence is 9.2*10-7, which is very low.Therefore, we can confirm that the structural design of the cold trap can be meet clinical requirements, not functional failure due to design.3.3 raw material: the cold snare is composed of a ferrule, an outer tube, a core rod, a slider, and a catheter assembly.The material, appearance and size of the raw materials are all qualified from the related lot numbers.3.4 production process: from the production process, we have checked all the processes related to the abnormality of the cold snare ferrule, and combined with the process risk analysis.3.4.1 threading the snare assembly: thread the snare assembly from the end of the outer tube to the positioning cap until the cable is extended, and ensure that the snare of the snare assembly is inserted into the left side of the outer tube.Take the cable in hand and the booster tube in the right hand, and insert the booster tube from the cable end.The booster tube and the cable are assembled.This process, if not done properly, may lead to bent of the snare.3.4.2 process inspection: visual inspection, the distance is 30~45cm, if the eye cannot judge, magnify and observe the inspection ferrule under the microscope, and can not observe the phenomenon of damage, broken wire, crack and scratch; this operation process is necessary the appearance of the ferrule is fully inspected, so the abnormality of the ferrule at this time can effectively identify product defects.3.4.3 microscopic inspection: punch out the ferrule from the outer tube, put it on the microscope table, and use a video microscope to conduct a complete inspection of the ferrule (front and back).There must be no breaks on the ferrule.Wires, scratches, burrs, damage and other phenomena; this operation process requires a full inspection of the ferrule, so at this time, abnormalities such as twisting and deformation of the ferrule can effectively identify product defects.Analysis: since 2020, we have sold a total of (b)(4) cold traps.According to statistics, this type of customer complaint is the second occurrence, with a probability of 9.2*10-7, which is very low.Therefore, we confirm that the production process is possible the failures caused are all identified and controlled before leaving the factory, indicating that there is no problem with the production process itself.3.5 instructions: cold snare is compatible with an endoscope channel of 2.8mm or larger.Retract the handle in order to make sure the snare loop is inside the outer tube.And insert the snare into the working channel of the endoscope.Via the endoscope view, make sure that the tube projects out of the distal end of the channel.Extend the snare loop, trap the polyps gently.Pull back the slider to removing polyps.Retract the handle in order to make sure the snare loop is inside the outer tube, and pull out cold snare.Repeat the procedure as necessary.Upon completion of the procedure, remove the instrument from the endoscope.The ifu clarifies the method of use: " extend the snare loop, trap the polyps gently, pull back the slider to removing polyps " 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 ifu.3.6 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.4.Conclusions: from the product's intended use, structural design, raw materials, production process, instructions for use, storage conditions, etc., we believe that the abnormality has nothing to do with the product itself, and the initial suspicion is that the polyp diameter of 20mm exceeds the scope of use.It is recommended to continue to pay attention to such anomalies.

• Brand Name: COLD SNARE
• Type of Device: SNARE, SURGICAL
• 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: 14785665
• MDR Text Key: 295349684
• Report Number: 3004837686-2022-00002
• Device Sequence Number: 1
• Product Code: GAE
• UDI-Device Identifier: 16932503550021
• UDI-Public: (01)16932503550021(17)240523(10)M190524302
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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: 05/23/2024
• Device Catalogue Number: CS3-11523230
• Device Lot Number: M190524302
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• 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