Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS SLEEVE 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON ENDO-SURGERY, LLC. BASX BLADELESS SLEEVE 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number CTB12LT
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p91c2z.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
 
Event or Problem Description
According to surgeon the tip of the sleeve breaks with very little movement of the instruments or while inserting in the abdominal wall with opturator.His concern is about the quality of the product and patient safety.Procedure: unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BASX BLADELESS SLEEVE 12MM
Common Device Name
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7556458
Report Number3005075853-2018-10273
Device Sequence Number13927780
Product Code GCJ
UDI-Device Identifier20705036001512
UDI-Public20705036001512
Combination Product (Y/N)N
PMA/510(K) Number
K062209
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberCTB12LT
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/10/2018
Initial Report FDA Received Date05/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-