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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ATRIAL RETRACTOR ENDOSCOPIC INSTRUMENT

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INTUITIVE SURGICAL,INC. ATRIAL RETRACTOR ENDOSCOPIC INSTRUMENT Back to Search Results
Model Number 420204-05
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was missing from the clevis. The crimp measures approximately 0. 032 x 0. 046. Other cables at the wrist were not damaged. A device history record review (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument. The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the failure mode were to recur.
 
Event Description
It was reported that during set up for a da vinci-assisted surgical procedure, while connecting physical damage was observed on the atrial retractor instrument. The planned procedure was completed and no patient harm, adverse outcome, or injury was reported. There were no reports of any fragment(s) falling into the patient. Intuitive surgical, inc. Has made multiple follow-up attempts for additional information. However, no additional information has been received as of date of this report.
 
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Brand NameATRIAL RETRACTOR
Type of DeviceENDOSCOPIC 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 Key7227881
MDR Text Key98733891
Report Number2955842-2018-00065
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420204-05
Device Lot NumberS10110127 661
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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