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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TENACULUM FORCEPS ENDOSCOPIC INSTRUMENT

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INTUITIVE SURGICAL,INC. TENACULUM FORCEPS ENDOSCOPIC INSTRUMENT Back to Search Results
Model Number 420207-07
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the instrument involved with this complaint and completed the device evaluation. Failure analysis investigation found that the instrument pitch cable was broken at the distal clevis hub. The cable segment that contained the crimp was missing from the clevis. No other damage or wear marks were observed on 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 during a da vinci assisted surgical procedure, the wire from the tenaculum forceps instrument was broken. The planned surgical 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.
 
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Brand NameTENACULUM FORCEPS
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 Key7243293
MDR Text Key99318682
Report Number2955842-2018-00077
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeKR
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 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420207-07
Device Lot NumberN10170816 856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
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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