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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE TIP COVER ACCESSORY

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INTUITIVE SURGICAL, INC NONE TIP COVER ACCESSORY Back to Search Results
Model Number 400180-14
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/06/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not yet received the monopolar curved scissors (mcs) tip cover accessory for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. Based on the information provided at this time, this complaint is being classified as a reportable event: it was reported that during the da vinci-assisted surgical procedure, the mcs tip cover accessory allegedly fell off inside the patient. The surgical staff was able to retrieve the mcs tip cover accessory during the same surgical procedure. However, at this time, the root cause of the customer reported failure mode is unknown. Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted nephrectomy procedure, the monopolar curved scissors (mcs) tip cover accessory installed on a mcs instrument allegedly fell off inside the patient. Prior to the procedure, the mcs tip cover accessory was installed normally and electro lube was applied to the jaws after the application of the tip cover. It was reported the mcs tip cover remained in place throughout the procedure without issues until they noticed orange along the instrument. The wrist was straightened and as the mcs instrument was being removed, the tip cover reportedly came off. The tip cover was retrieved and a replacement tip cover was installed to complete the planned procedure. On february 26, 2018, intuitive surgical, inc. (isi) obtained the following additional information from the surgeon about the complaint: the mcs instrument did not collide with any other instrument during the surgical procedure. The mcs tip cover accessory was observed to have been properly installed with the blue installation tool. There was no report of over-installation of the tip cover. About 2 hours into the procedure, a bit of orange surface was seen along the instrument. As the instrument was being removed, the tip cover was visibly seen falling off. After the event occurred, the site inspected the mcs instrument, mcs tip cover accessory, and cannula. No damage was found with the inspection of the instrument or instrument accessories. There was no report of post-operative complications and the patient was discharged as expected.
 
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Brand NameNONE
Type of DeviceTIP COVER ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale, CA 94086
4085232100
MDR Report Key7308157
MDR Text Key101589186
Report Number2955842-2018-10033
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Lot NumberM10171109
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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