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U.S. Department of Health and Human Services

Class 2 Device Recall AQUABEAM Handpiece

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  Class 2 Device Recall AQUABEAM Handpiece see related information
Date Initiated by Firm July 09, 2021
Create Date August 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-2330-2021
Recall Event ID 88337
510(K)Number K202961  
Product Classification Fluid jet removal system - Product Code PZP
Product AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Code Information Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527
Recalling Firm/
Manufacturer		 PROCEPT BIOROBOTICS CORPORATION
900 Island Dr Ste 101
Redwood City CA 94065-5176
Manufacturer Reason
for Recall		 Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.
FDA Determined
Cause 2		 Component change control
Action On 07/09/21 Voluntary Medical Device Recall notices were mailed to customers. Customers were asked to take the following actions if tip detachment occurs: If the scope tube tip detaches from the telescoping tube before insertion into the patient during preparation, the Handpiece must be replaced with a new Handpiece. If the scope tube tip detaches after the Handpiece has been inserted into the patient, this is seen cystoscopically and the Handpiece must be removed and replaced with a new Handpiece. In the event that the scope tube tip separates from the Handpiece entirely, the scope tube tip may fall into the bladder or the prostate. The standard 26Fr resectoscope, used in an Aquablation procedure, will accommodate the removal of the detached scope tube tip. In addition, customers were asked to take the following actions: 1) Read the notice. 2) Stop using affected devices. 3) Remove affected lots from their regular inventory location and segregate for future return and replacement. 4) Complete and return the acknowledgement form. 5) Pass along the notice to all that need to be aware. Customers with questions were encouraged to contact Customer Service: 1.650.232.7222 or e-mail cs@procept-biorobotics.com.
Quantity in Commerce 608
Distribution Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, WI, AZ, AR, MI, WV, SD, PA, CA, DC, NJ, NY, GA, IN, VA, TN and the countries of Austria, Switzerland, Germany, Spain, France, UK, Italy.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PZP and Original Applicant = PROCEPT BioRobotics Corporation
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