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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. PERMANENT CAUTERY HOOK; SYSTEM, SURGICAL, COMPUTER,
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INTUITIVE SURGICAL, INC. PERMANENT CAUTERY HOOK; SYSTEM, SURGICAL, COMPUTER, Back to Search Results
Model Number 420183
Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2016
Event Type  malfunction  
Event Description
Surgeon performing robotic hysterectomy using all three arms of the robot.When he went to readjust the hook for cautery, he saw that the hook was bent and part of the plastic coating was missing.The device is missing the plastic portion on the distal tip.It is unclear when the tip broke, as the physician had been using it prior to noticing that it was broke.Complete inspection of the abdomen and pelvis did not reveal the fragment; possibly it was retained.Per hospital, the manufacturer provided hospital with a permanent cautery biocompatibility letter.
 
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Brand Name
PERMANENT CAUTERY HOOK
Type of Device
SYSTEM, SURGICAL, COMPUTER,
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale CA 94086
MDR Report Key6248996
MDR Text Key64750289
Report Number6248996
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number420183
Device Lot NumberN10160913 401
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/04/2017
Event Location Hospital
Date Report to Manufacturer01/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
3 ROBOTIC ARMS WITH INSTRUMENTS ATTACHED WERE BEIN; NO OTHER THERAPIES
Patient Age45 YR
Patient Weight65
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