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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM TENACULUM FORCEPS ENDOSCOPIC INSTRUMENT

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INTUITIVE SURGICAL,INC. 8 MM TENACULUM FORCEPS ENDOSCOPIC INSTRUMENT Back to Search Results
Model Number 470207-08
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/16/2018
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. This complaint is being reported due to the following conclusion: during a da vinci-assisted myomectomy procedure, fragment(s) from the instrument broke off and fell inside the patient. The broken fragment(s) were retrieved without patient harm, adverse outcome or injury. Furthermore, failure analysis investigation confirmed a broken pitch cable and the broken fragment was a crimp from the tenaculum forceps instrument. A broken pitch cable could cause or contribute to an adverse event if the malfunction were to recur.
 
Event Description
It was reported that during a da vinci-assisted myomectomy procedure, the wires from the tenaculum forceps instrument broke and fragment(s) fell inside the patient. The surgeon was able to retrieve the fragment(s) with a laparoscopic instrument and the planned surgical procedure was completed. There was no report of any patient harm, adverse outcome or injury.
 
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Brand Name8 MM TENACULUM 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 Key7227920
MDR Text Key98846053
Report Number2955842-2018-00066
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K013416
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/16/2018
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
Device Model Number470207-08
Device Lot NumberN10170829 0076
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 Received01/16/2018
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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