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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM SMALL GRASPING RETRACTOR ENDOSCOPIC INSTRUMENT

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INTUITIVE SURGICAL,INC. 8 MM SMALL GRASPING RETRACTOR ENDOSCOPIC INSTRUMENT Back to Search Results
Model Number 470318-08
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
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 in the clevis. Missing crimp was approximately 0. 046 x 0. 032. The clevis did not exhibit any damage or wear marks. A device history record (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 a da vinci-assisted surgical procedure, a string broke loose on the grasping retractor instrument and the jaws no longer functioned. There was no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. Has attempted to follow up with the initial reporter to obtain additional information, however, no additional information has been obtained as of date of this report.
 
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Brand Name8 MM SMALL GRASPING 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 Key7307079
MDR Text Key101569539
Report Number2955842-2018-00109
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 02/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470318-08
Device Lot NumberN10160726
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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