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

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. HARMONIC ACE CURVED SHEARS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

  • 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
 

INTUITIVE SURGICAL,INC. HARMONIC ACE CURVED SHEARS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 480275-08
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/12/2017
Event Type  malfunction  
Manufacturer Narrative
The instrument will not be returned to isi for failure analysis as the customer indicated that it may have been discarded; therefore, the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if additional information is received. Based on the provided information, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that a fragment from the harmonic ace curved shears instrument broke off and fell inside the patient. Although, the fragment was retrieved and no patient harm, adverse outcome or injury was reported it is unknown what caused the breakage to occur.
 
Event Description
It was reported that during a da vinci-assisted thymectomy procedure, the metal part on the jaw of the harmonic ace curved shears instrument broke off and fell inside the patient. The piece was retrieved with no issues and no x-ray was performed. There was no report of patient harm, adverse outcome or injury. On october 13, 2017, intuitive surgical inc. (isi) obtained the following information from the initial reporter regarding the reported event: the patient is stable following surgery and did not suffer any injuries due to the incident. The instrument was in use about 10 to 15 minutes and while dissecting the instrument broke. The piece that broke off was removed with a laparoscopic instrument through an assistant port during the same procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHARMONIC ACE CURVED SHEARS
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7001274
MDR Text Key91352887
Report Number2955842-2017-00731
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480275-08
Device Lot NumberM10170614
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 Received10/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-