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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 Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2017
Event Type  malfunction  
Manufacturer Narrative
The instrument has not been returned to isi for evaluation. Therefore, the root cause of the customer reported failure mode cannot be determined. If additional information is received, a follow-up mdr will be submitted. Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment from the tenaculum forceps fell inside the patient. The fragment was retrieved and no additional surgical intervention was required. However, unintended fragment(s) falling into the patient may require surgical intervention. At this time, it is unknown what caused the cable to fall inside the patient.
 
Event Description
It was reported that after completion of a da vinci-assisted myomectomy procedure, a fragment from the tenaculum forceps instrument broke off and fell inside the patient. The fragment was retrieved during the same da vinci procedure. The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported.
 
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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 Key7001690
MDR Text Key92071839
Report Number2955842-2017-00736
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
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 10/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420207-07
Device Lot NumberN10161222
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 Received10/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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