• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX, INC. WECK 8MM BLADELESS OBTURATOR LAPAROSCOPE, GENERAL & 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
 

TELEFLEX, INC. WECK 8MM BLADELESS OBTURATOR LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 420023
Device Problems Component Missing (2306); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2020
Event Type  Malfunction  
Event Description

Pt was undergoing a robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy, cystoscopy. The surgeon placed the camera port into the abdomen. After the obturator was removed, it was noted that the tip of the trocar was missing. The team could not confirm the tip was present prior to incision or it had broken off in the abdomen. The camera was advanced and the abdomen surveyed. The plastic tip was not visualized in the abdomen or on the field. A new obturator was obtained and confirmed to be intact prior to use. The procedure was able to be completed. Fda safety report id# (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWECK 8MM BLADELESS OBTURATOR
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
TELEFLEX, INC.
morrisville NC
MDR Report Key9711459
MDR Text Key180043169
Report NumberMW5093004
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number420023
Device LOT Number73H1800102
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/13/2020 Patient Sequence Number: 1
-
-