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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 400180
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/10/2017
Event Type  malfunction  
Manufacturer Narrative
The mcs tip cover accessory was not returned to isi for evaluation. Therefore, the root cause of the customer reported issue cannot be determined. The mcs instrument was returned to isi and evaluated. The instrument's tube extension was found to be broken. The damaged area measured approximately 0. 224 x 0. 287. A broken off piece was not returned with the instrument. The known common cause of the failure is due to mishandling/misuse. The instrument tube extension was inspected for cracks and there were no cracks found. Isi has reviewed the site's system logs and determined that the mcs instrument involved with the reported event was last used on (b)(6) 2017, not (b)(6) 2017 based on follow-up information obtained on 12/08/2017. No related system errors were found to have occurred during the surgical procedure. 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 mcs tip cover accessory 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 mcs tip cover accessory fragment to fall inside the patient.
 
Event Description
It was initially reported that during a da vinci-assisted surgical procedure, the tip of the monopolar curved scissors (mcs) instrument allegedly slipped and fell inside the patient's abdomen. On 12/08/2017, intuitive surgical, inc. (isi) obtained the following additional information regarding the reported event from the site: the mcs instrument was inspected prior to use. No additional anesthesia was administered due to the reported instrument issue. The instrument tip was found and removed during the same surgical procedure which reportedly occurred on (b)(6) 2017. In addition, no post-operative complications were reported. On 12/12/2017, isi contacted the site and confirmed that the instrument tip that allegedly fell inside the patient's abdomen was actually a mcs tip cover accessory and not an instrument fragment.
 
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Brand NameTIP COVER ACCESSORY
Type of DeviceENDOSCOPIC ELECTROSURGICAL 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 Key7199462
MDR Text Key97920937
Report Number2955842-2018-00032
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180
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 Received12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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