MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. SINGLE-USE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number DG-18-08-21

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Our distributor communicated with the hospital, the hospital is unable to provide relevant complaints and other information about the use process.Due to not received complained products, 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.In order to investigate the causes of possible bending after use, only off-site clinical simulation analysis can be carried out.Confirm whether there will be abnormal customer phenomenon after use.The simulation analysis of the production sample of m190917103 is as follows: a.The appearance of the sample was observed and no abnormality was found.B.According to the customer's feedback, the product is a kind of bending during duodenoscopy.In order to simulate this state, olympus tjf-260v duodenoscopy was used for field simulation.C.In order to simulate the possible production bending, we coil the endoscope and bend the elevator to the maximum limit.After more than 20 times of insertion and extraction, the product itself does not have rigid bending, so the simulated product does not affect the use.4.The production process of the product is checked, there is no risk found which could led to this issue.Based on the above simulation analysis and process investigation, the possible causes of product bending were not found.We will continue to monitor this issue to ensure patient safety.

Event Description

On 10/14/2020, we found an alleged complaint regarding single-use marked spring tip guidewire through maude.Report number: (b)(4).It was reported that "egd (esophagogastroduodenoscopy) guidewire kinked at some point during its removal from the patient.No known impact or consequence to patient." mt qa had an investigation about this complaint, the device was not returned to analyze so far. there is no further information provided about this complaint.

• Brand Name: SINGLE-USE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 10789896
• MDR Text Key: 252823264
• Report Number: 3004837686-2020-00006
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,literature
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/05/2020

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: 09/16/2021
• Device Catalogue Number: DG-18-08-21
• Device Lot Number: M190917103
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 55