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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. REDUCER CAP

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INTUITIVE SURGICAL,INC. REDUCER CAP Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
The reducer cap will not be returned to isi for failure analysis as it was discarded by the customer; therefore, the root cause of the customer reported failure mode cannot be determined; however, the customer did provide a photograph of the reducer cap and the broken fragment. Based on the photographic inspection, it's possible that contact with a sharp object was made causing the duckbill to tear but it could not be confirmed. A follow-up mdr will be submitted if additional information is received. Based on the provided information, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that the reducer cap fell inside the patient and was retrieved. Although no patient harm, adverse outcome or injury was reported it is unknown what caused the rubber piece to fall inside the patient.
 
Event Description
It was reported that during a da vinci-assisted ventral hernia procedure, the 5 mm reducer cap rubber fell inside the patient. The piece was retrieved without issues. There was no report of patient harm, adverse outcome or injury. On january 05, 2018, intuitive surgical, inc. (isi) obtained the following additional information from the isi clinical sales representative (csr): the patient was fine and did not suffer any injuries as a result of the reported incident. The reducer cap was removed immediately from the patient. The csr was unsure as to what caused the reducer cap rubber to fall inside the patient. The surgeon was performing a hernia suturing when the event occurred. No post operative test or x-ray was performed as the fragment was immediately removed. There were no collision of other instruments or tools. The piece will not be returned to isi as it was disposed of.
 
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Brand NameREDUCER CAP
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 Key7227186
MDR Text Key98981449
Report Number2955842-2018-00063
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 Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/03/2018
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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