MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 2200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE®) - DE; SURGICAL PNEUMATIC TOURNIQUET SYSTEM

Model Number N/A

Device Problems Deflation Problem (1149); Gas/Air Leak (2946)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.

Event Description

It was reported that during instrument check prior to surgery, the reservoir had an air leak and the device spontaneously deflated.There was no adverse event associated with this malfunction.Due diligence is complete and there is no additional information available.

Manufacturer Narrative

This device did not cause or contribute to serious injury.Therefore this is not reportable; the initial report was forwarded in error and should be voided.

Event Description

This device did not cause or contribute to serious injury.Therefore this is not reportable; the initial report was forwarded in error and should be voided.

• Brand Name: A.T.S. 2200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE®) - DE
• Type of Device: SURGICAL PNEUMATIC TOURNIQUET SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16136785
• MDR Text Key: 308243326
• Report Number: 0001526350-2023-00031
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 60220030107
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1