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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 470205-17
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps instrument involved with this complaint for evaluation and failure analysis was completed. Failure analysis confirmed the customer's complaint of a damaged conductor wire. The instrument was found to have damage to the conductor wire's insulation and the internal wires were visibly exposed. The instrument passed the electrical continuity test. The root cause of this failure is attributed to a component failure. Preliminary image review completed prior to the product being returned indicated that the fenestrated bipolar forceps instrument appeared to have a damaged conductor wire insulation with a potentially visible exposed wire. A review of the instrument log for the fenestrated bipolar forceps instrument lot# n10210316 / sequence 0176 associated with this event has been performed. Per logs, the instrument was last used for a procedure on (b)(6) 2021 on system (b)(4). The instrument had 9 remaining usable lives with no subsequent use recorded. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. The fenestrated bipolar forceps instruments are multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu). The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended. The energy is activated by pressing the designated pedal on the surgeon side console (ssc). This complaint is being reported based on the following conclusion: the complaint reported conductor wire damage on the fenestrated bipolar forceps instrument. A preliminary analysis of the photo provided by the customer identified what was likely conductor wire insulation damage with a potentially exposed wire without claim of ¿loss of cautery. ¿ failure analysis additionally confirmed that the conductor wire had damaged insulation, wires were visibly exposed, and the instrument passed the 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.
 
Event Description
It was reported that during central processing, the customer conducted an inspection and found that the conductor wire of the fenestrated bipolar forceps instrument was damaged. There was no patient involvement. Intuitive surgical, inc. (isi) followed up with the site; however, no additional information regarding the reported event was provided.
 
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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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key11937335
MDR Text Key254828320
Report Number2955842-2021-10614
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 05/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470205-17
Device Catalogue Number470205
Device Lot NumberN10210316 0176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2021
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

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