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

MAUDE Adverse Event Report: MEDLINE RENEWAL ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 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
 

MEDLINE RENEWAL ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM Back to Search Results
Catalog Number HAR36MRH
Device Problems Break (1069); Tip (3123); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2019
Event Type  Malfunction  
Manufacturer Narrative

It was reported that during a hysterectomy, the tip of the reprocessed harmonic ace®+ shears w/o adaptive tissue technology 36cm broke off and fell into surgical site. Per report, the device tip was successfully retrieved from the patient through an unidentified method. There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to this incident. Due to the reported event and required medical intervention to retrieve the device tip from the surgical site, this medwatch is being filed. The device is not available to be returned for evaluation. A definitive root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.

 
Event Description

It was reported that the tip of the reprocessed ethicon harmonic ace®+ shears w/o adaptive tissue technology 36cm broke off and fell into the surgical site.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETHICON
Type of DeviceHARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM
Manufacturer (Section D)
MEDLINE RENEWAL
1500 ne hemlock ave
redmond OR 97756
Manufacturer Contact
stephen wilson
1500 ne hemlock ave
redmond, OR 97756
MDR Report Key8448278
MDR Text Key139994161
Report Number3032391-2019-00003
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHAR36MRH
Device LOT Number393871
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/07/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/25/2019 Patient Sequence Number: 1
-
-