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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 Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2019
Event Type  malfunction  
Manufacturer Narrative
Isi has requested the monopolar curved scissors (mcs) tip cover accessory to be returned for evaluation. However, as of the date of this report, isi has not received the product. Therefore, the root cause of the customer reported failure mode could not be determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. The customer reported complaint does not itself constitute an mdr reportable event; however, evidence of arcing found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.
 
Event Description
It was reported that after successfully completing a da vinci-assisted surgical procedure, the customer inspected the instruments and accessories and found a crack on the monopolar curved scissors (mcs) tip cover accessory. The reporter was unable to specify how the mcs tip cover accessory was damaged. There was no report of a fragment falling into the patient. No known impact or patient consequence was reported. Intuitive surgical inc. (isi) obtained the following additional information regarding the reported event: the mcs tip cover accessory was installed into the mcs instrument using an installation tool. The mcs instrument operated without issue and no arcing was observed during the procedure.
 
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Brand NameNONE
Type of DeviceTIP COVER ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key9235274
MDR Text Key191741816
Report Number2955842-2019-10854
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Lot NumberM90190410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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