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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 Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
Event Description
It was reported that during central processing, the fenestrated bipolar forceps instrument had a frayed cable. There was no report of patient involvement.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps instrument and performed a device evaluation. Failure analysis confirmed the customer reported issue. Failure analysis found the instrument had a broken main tube extension. The main tube breakage was observed to be where the main tube extension meets the proximal clevis at the distal end. A broken piece was not returned, measuring roughly 0. 25" x 0. 04¿ in size. Instrument main tube extension breakages are typically attributed to mishandling/misuse. The following was found during the device evaluation, but is not related to the reportable finding: the instrument was found to have a broken conductor wire at the wrist. The instrument failed the electrical continuity test. No signs of thermal damage or loss of conductor wire insulation were observed. Root cause of broken conductor wire is attributed to a component failure. No functional test for energy activation could be performed due to the wire breakage. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the device logs for the fenestrated bipolar forceps (part# 471205-17| lot-sequence# n14200622- 0086) associated with this event has been performed. Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2021 during a colon resection on system serial# (b)(4). No image or video clip for the reported event was submitted for review. This complaint is being reported because failure analysis identified a fragment was missing from a portion of the device that enters the patient. Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure. While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
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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 Key13595805
MDR Text Key288189367
Report Number2955842-2022-10347
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 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
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 NumberN14200622 0086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
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: 02/24/2022 Patient Sequence Number: 1
Treatment
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