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

Model Number TM6000

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/31/2018

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.

• Brand Name: INSUFFLATOR TUBING SET
• Type of Device: INSUFFLATOR TUBING SET
• Manufacturer (Section D): ADVANCED MEDICAL DESIGN CO., LTD; 4f-5f, no29, wuquan 5th rd; wugu dist; new taipei city, 24888 ; TW 24888
• Manufacturer (Section G): ADVANCED MEDICAL DESIGN CO., LTD; 4f-5f, no29, wuquan 5th rd; wugu dist; new taipei city, 24888 ; TW 24888
• Manufacturer Contact: arnold yeh ; 4f-5f, no29, wuquan 5th rd; wugu dist; new taipei city, 24888 ; TW 24888
• MDR Report Key: 8300630
• MDR Text Key: 137004736
• Report Number: 3010570913-2019-00001
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: TM6000
• Device Lot Number: 1727955
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR