• 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 ETHICON ACE+7 LAPAROSCOPIC SHEARS 5MM 36CM

  • 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 ETHICON ACE+7 LAPAROSCOPIC SHEARS 5MM 36CM Back to Search Results
Lot Number M91E71
Event Date 12/02/2015
Event Type  Malfunction  
Event Description

A (b)(6) female came into the operating room and underwent laparoscopic bilateral tubal ligation. A piece of the grasper broke off inside the patient's abdomen. Dr (b)(6) saw the piece that had fallen off the wand and was able to retrieve it from the patient's abdomen without difficulty.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETHICON
Type of DeviceACE+7 LAPAROSCOPIC SHEARS 5MM 36CM
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
475 calle c.
guaynado PR 00969
MDR Report Key5350401
Report Number5350401
Device Sequence Number1
Product CodeLFL
Report Source User Facility
Reporter Occupation RISK MANAGER
Report Date 12/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT NumberM91E71
OTHER Device ID NumberREF HARJ36
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2015
Distributor Facility Aware Date12/02/2015
Device Age na
Event Location Hospital
Date Report TO Manufacturer12/11/2015
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/29/2015 Patient Sequence Number: 1
-
-