MAUDE Adverse Event Report: THS INTERNATIONAL, INC. D/B/A ACCORDION MEDICAL ACCORDION COAX; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number PA 1305-01-15

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2021

Event Type  Injury  

Event Description

Product used during (b)(6) 2021 urological surgery.During a (b)(6) 2021 urological surgery a 1.25 inch plastic fragment was seen and removed.Fda safety report id # (b)(4).

• Brand Name: ACCORDION COAX
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): THS INTERNATIONAL, INC. D/B/A ACCORDION MEDICAL; 9465 counselors row, suite 200; indianapolis IN 46240
• MDR Report Key: 11706206
• MDR Text Key: 247053774
• Report Number: MW5100933
• Device Sequence Number: 1
• Product Code: FFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PA 1305-01-15
• Device Lot Number: AB 57
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 74