MAUDE Adverse Event Report: ADVANCED MEDICAL DESIGN CO., LTD. INSUFFLATOR TUBING SET

Model Number TM6000

Device Problem Obstruction of Flow (2423)

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

Event Date 01/08/2019

Event Type  malfunction  

Event Description

Describe the event or problem: during use the insufflation tubing occiuded.What was the original intended procedure? : lap appy.What problem dld the user have? device malfunction that is, the device did not do what it was supposed to do.

Manufacturer Narrative

In general, the air flow rate of insufflation tubing set would be 20 l/min during the clinical situation.Therefore, we set a pressure of air output as 20 l/min and then apply to returned sample to see whether occlusion happens.The intended use of insufflation tubing set is to filter and deliver insufflation gas (co2) from an insufflation pump to an insufflation needle or suitable laparoscopic port as a means to provide peritoneal insufflation and allow for the manipulation of instruments during laparoscopic procedures.And the description of the complaint mentioned that the device was occluded.However, after investigating the returned sample, it was quiet good to provide the function of intended use and reach the rate of clinical requirement.The malfunction was not found, besides, there was no further information or scenarios during the use gave to amd.Summary according to investigation above, the function of insufflation tubing set is good and provide what it should do for clinical requirement.

• Brand Name: INSUFFLATOR TUBING SET
• Type of Device: INSUFFLATOR TUBING
• Manufacturer (Section D): ADVANCED MEDICAL DESIGN CO., LTD.; 4-5f., no. 29, wuquan 5th rd.,; wugu dist.,; new taipei city, 248 ; TW 248
• Manufacturer (Section G): ADVANCED MEDICAL DESIGN CO., LTD.; 4-5f., no. 29, wuquan 5th rd.,; wugu dist.; new taipei city, 248 ; TW 248
• Manufacturer Contact: jason chen ; 4-5f., no. 29, wuquan 5th rd.,; wugu dist.; new taipei city, 248 ; TW 248
• MDR Report Key: 17582953
• MDR Text Key: 321809593
• Report Number: 3010437008-2023-00005
• Device Sequence Number: 1
• Product Code: NKC
• UDI-Device Identifier: 04711605992114
• UDI-Public: (01)04711605992114(17)201230(10)1727955
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2020
• Device Model Number: TM6000
• Device Catalogue Number: TM6000
• Device Lot Number: 1927955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• 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: 26 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic