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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 05/26/2021
Event Type  malfunction  
Event Description
It was reported that during central processing, the 8mm fenestrated bipolar forceps instrument cable had black coating torn/damaged. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information on (b)(6) 2021: the fenestrated bipolar forceps instrument had broken black cable. There was no patient injury and there were no fragments fell into the patient. The instrument was used prior to use and there was nothing abnormal noticed during its inspection. It is unknown if there was an arcing or thermal damage observed. The patient demographic information is not available.
 
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) confirmed the customer reported complaint. Failure analysis found the primary failure of conductor wire damaged insulation to be related to the customer reported complaint. The instrument was found to have insulation damage on the conductor wire, exposing the internal wires. The damage was located at the distal end on the bipolar yaw pulley. No material missing and no thermal damage was observed. Electrical continuity was tested and passed and the root cause attributed to a component failure. Failure analysis found the secondary failure of distal clevis scratch marks/abrasions to be related to the customer reported complaint. The instrument was found to exhibited scratch marks on the distal clevis and the scratch marks were relative to the conductor wire insulation damage at the distal end and the root cause is typically attributed to mishandling/misuse. Additional observations not reported by the site were also identified. The fenestrated bipolar forceps instrument was found to have scratch marks on the bipolar yaw pulley and the root cause is typically attributed to mishandling/misuse. A review of the instrument log for the fenestrated bipolar forceps (471205-17/n102011170094) 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 7 uses 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 was provided for review. This complaint is being reported due to the following conclusion: the fenestrated bipolar forceps instrument had black coating charred with no evidence or claim of user mishandling or misuse. The allegation could be related to the 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.
 
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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 Key13091170
MDR Text Key290274837
Report Number2955842-2021-11818
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 Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
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 NumberN10201117 0094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2020
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: 12/27/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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