• 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. ENDOPATH XCEL BLADELESS TROCAR; 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. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Model Number B12SRT
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.
 
Event Description
It was reported that during a laparoscopic colectomy, the valve was broken off 10 minutes after the beginning of use.The broken valve and forceps fell outside the patient.The device was used on the colon.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.
 
Manufacturer Narrative
(b)(4).Date sent: 2/11/2020.Investigation summary: the analysis results found that the b12srt device was received with the valve of stopcock damaged.No functional test was performed due the condition of the device.In addition, a piece of plastic was returned inside of a plastic bag.It is possible that the damaged valve was due to improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.
 
Manufacturer Narrative
(b)(4).Date sent: 1/17/2020.H2: additional information: the device was received for evaluation, however evaluation not yet begun.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOPATH XCEL BLADELESS TROCAR
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key9507128
MDR Text Key202572620
Report Number3005075853-2019-24696
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036001188
UDI-Public10705036001188
Combination Product (y/n)N
PMA/PMN Number
K032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/04/2019
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
Device Operator Health Professional
Device Model NumberB12SRT
Device Catalogue NumberB12SRT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received01/06/2020
01/17/2020
Supplement Dates FDA Received01/17/2020
02/11/2020
Patient Sequence Number1
-
-