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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 471205-17
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the 8mm fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/confirmed the customer reported complaint. Failure analysis found the primary failure of damaged conductor wire insulation to be related to the customer reported complaint. For clarification, the fenestrated bipolar forceps instrument was found to have damage to the conductor wire¿s insulation at the distal end. The conductor wire was exposed as a result. The instrument passed the electrical continuity test. No signs of thermal damage were observed. The root cause of this failure was attributed to a component failure. A review of the instrument log for the fenestrated bipolar forceps (471205-17/k112107120243) associated with this event has been performed. Per logs, the fenestrated bipolar forceps instrument was last used on (b)(6) 2021 on system (b)(4). The instrument had 1 use remaining after the last procedural use. A review of the site's complaint history does not show any additional complaints related to this product. No image or video of the last procedure was provided for review. This complaint is being reported due to the following conclusion: during failure analysis testing, the fenestrated bipolar forceps instrument was found to have conductor wire damage with exposed internal wires and a passed electrical continuity test. The damaged conductor wire has potential for electrical discharge at a location other than intended. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure that the 8mm fenestrated bipolar forceps instrument had broken or loose cable. The procedure was completed with no reports of patient injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameENDOWRIST
Type of DeviceFENESTRATED BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13102388
MDR Text Key290536564
Report Number2955842-2021-11828
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205-17
Device Catalogue Number471205
Device Lot NumberK11210712 0243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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