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

Catalog Number	DC0235W
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Dr.(b)(6) did a gpoem last week and the patient ended up needing a second procedure due to almost all of the clips falling off.
Additional Manufacturer Narrative
1.Description dr.Adler did a gpoem last week and the patient ended up needing a second procedure due to almost all of the clips falling off.2.External investigation on september 18, 2024, micro-tech has communicated with the customer to ask if there is any other clinical usage information.On september 27, 2024, the customer replied that they were temporarily unable to provide pictures.It was found during the postoperative review that the clips fell off, and it was temporarily impossible to confirm whether the fallen clips were in the open or closed state.Meanwhile, micro-tech will conduct an internal investigation and analysis.3.Internal investigations the investigation and analysis were carried out from the aspects of structural design, raw materials, production process, technical standards, inspection methods, operation methods and environment, storage and transportation, as follows: 3.1 structural design the working principle of the clip is: the effective length of the clip that can be rotated and repeatedly opened and closed enters the endoscope cavity, and the clip component contacts the mucosal tissue.The outer tube and the endoscope contact the spring tube and the clip component are mechanically connected.The slider transfers force to the clip to achieve opening and closing, and achieves repeated opening and closing performance through the slide groove of the clip.By using the self-locking structure of the clip itself, the clip is closed and separated from the outer tube, thereby completing the release of the clip.The function of the clip to clamp tissue is achieved by using the self-locking structure of the clip itself to close the clip and compress the tissue.Therefore, this performance is related to the structure of the front clip component.The self-locking structure is achieved by hanging the tail of the clip on the hanging table of the clip seat.After the clip takes tissue, the tail of the clip is hung on the platform of the clip seat to achieve the locking of the clip.The structural characteristics and working principle of the clip itself can ensure that the clip can clamp tissue well and will not fall off.3.2 raw materials the part that realizes the clamping of the clip is the clip component, and the clip components are all made of stainless steel.The material strength and hardness can meet the requirement of keeping the clip closed after closure without being stretched by the tissue.We did not receive any customer complaints about the clips falling off due to material problems.Therefore, we confirm that the selection of the clip material can meet the usage requirements, and it is not a functional failure caused by the material.We checked the inspection batch of the clip raw materials, and the raw material meets the requirements.The appearance and size of other measurements are also qualified for inspection and storage.Therefore, the phenomenon of the clip falling off after clamping this time is unrelated to the material, size, appearance, etc.3.3 technical standards clamping force: after the clip is clamped on a 1mm silicone film for clamping, a 0.6n weight is applied to the clip pedestal, and the clip should remain stationary for 1 minute without falling off.We reviewed the production records (dhr) and confirmed that the clips were executed according to the operating procedures and inspection procedures, and the clamping force indicators were consistent with the technical requirements.Therefore, we confirmed that the batch of products met the requirements.3.4 inspection methods clamping force: fix the silicone film on the bench or other device and keep it still.The clip presses against the typing paper, slowly pulls the slider towards the proximal end, clamps the typing paper, and continues to pull the slider towards the proximal end until the clip separates from the transition cap.Put metal wire or wire on the tail of the clip pedstal, and ensure that the clamp does not deform during operation.Add 0.6n weight to the line.The clamping force performance of the clamp is related to its clamping ability.During the design and development stage, a detailed analysis was conducted to transform the clamping tissue performance into a technical specification that can ensure the safety and effectiveness of the product.The clamping force test was used to identify possible design faults.At the same time, a large amount of clinical data can prove that the setting of the clamping force test method can objectively meet the expected use of the product's clamping tissue.Therefore, we confirm that the setting of the clamping force test method can objectively meet the requirements of the clamping performance of the clip, and there is no problem with the setting of the test method.3.5 operation methods and environment operating environmental factors: the clamping method for tissue may be parallel and transverse clamping.In the case where the granuloma has not yet formed on the wound surface, the clip may fall off and cause bleeding.It is recommended to use an upright clamping method for clamping, with the clamp perpendicular to the wound surface, and the two claws grasping the mucous membranes on both sides respectively, attracting and narrowing the wound surface, and then appropriately pressing the clip to tighten the clamping.Parallel transverse clamping is when the clip is parallel to the wound surface, with the arms placed on both sides, attracting and applying appropriate downward pressure to perform transverse clamping from the bottom of the wound surface (reference: endoscopic mucosal resection for the treatment of colorectal polyps.The influence of metal titanium clamp clamping method on delayed bleeding, no.1673-6087 (2015) 04-0272-04 mentions delayed bleeding, and there is a corresponding relationship between clamp detachment and clamping method).4.Summary no abnormalities were found in the aspects of structural design, raw materials, technical standards, inspection methods, operating environment factors, and storage and transportation.The possible reasons for the detachment were analyzed through literature search and analysis as follows: operating environment, the clamping method of the tissue may be parallel transverse clamping, and the clip may fall off and cause bleeding when the granuloma has not yet formed on the wound surface.It is recommended to use the upright clamping method for clamping, with the clamp perpendicular to the wound surface, and the two claws respectively grasping the mucous membranes on both sides to attract and shrink the wound surface, and then appropriately press the clip to tighten the clamping.Parallel transverse clamping is when the clip is parallel to the wound surface, with the arms placed on both sides, attracting and applying appropriate downward pressure to perform transverse clamping from the bottom of the wound surface (reference: endoscopic mucosal resection for the treatment of colorectal polyps.The influence of metal titanium clamp clamping method on delayed bleeding, no.1673-6087 (2015) 04-0272-04 mentions delayed bleeding, and there is a corresponding relationship between clamp detachment and clamping method).

• 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: 20329567
• Report Number: 3004837686-2024-00007
• Device Sequence Number: 8096775
• Product Code: PKL
• UDI-Device Identifier: 16932619740033
• UDI-Public: (01)16932619740033(17)250228(10)M220301592
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150434
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: DC0235W
• Device Lot Number: M220301592
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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
• Patient Sex: Unknown