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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST TENACULUM FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST TENACULUM FORCEPS Back to Search Results
Model Number 470207-08
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2018
Event Type  malfunction  
Manufacturer Narrative
The instrument was returned to intuitive surgical, inc. (isi) and evaluated. Failure analysis confirmed the customer reported complaint of a ¿broken cable¿. 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. 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 in central processing, a broken cable was identified on the tenaculum forceps instrument. There was no report of a patient injury.
 
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Brand NameENDOWRIST
Type of DeviceTENACULUM FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale, CA 94086
4085232100
MDR Report Key7626685
MDR Text Key112502102
Report Number2955842-2018-10310
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
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 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470207-08
Device Lot NumberN101705090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2017
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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