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. 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
Catalog Number B12LT
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2023
Event Type  malfunction  
Event Description
It was reported that the front end of trocar was broken during the unknown procedure.Changed the new one to complete surgery.No additional information can be provided.
 
Manufacturer Narrative
(b)(4).Date sent: 12/15/2023 d4: batch # unk additional information was requested and the following was obtained: "were there any patient consequences? if yes, please describe.-no did any pieces fall into the patient? if yes, were they retrieved? -yes, they were retrieved." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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
*  00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
*   00969
Manufacturer Contact
kate karberg
475 calle c
guaynabo 
*  
3035526892
MDR Report Key18335277
MDR Text Key330676706
Report Number3005075853-2023-09475
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036001164
UDI-Public10705036001164
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2023
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 Catalogue NumberB12LT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/16/2023
Initial Date FDA Received12/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-