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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TENACULUM FORCEPS
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INTUITIVE SURGICAL, INC ENDOWRIST; TENACULUM FORCEPS Back to Search Results
Model Number 470207-10
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Event Description
It was reported during central processing, the 8mm tenaculum forceps instrument had snapped cable.There was no report of patient involvement.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.
 
Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8mm tenaculum forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed/replicated the customer reported complaint.Failure analysis found the primary failure of a broken pitch cable to be related to the customer reported complaint.The tenaculum forceps instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.The root cause of the broken pitch cable was attributed to a component failure and related to device design.A review of the instrument log for the tenaculum forceps (470207-10/ n101903050106) associated with this event has been performed.Per logs, the tenaculum forceps was last used on (b)(6) 2021 on system sk2731.The alleged instrument had 6 uses remaining after the last procedural use.A review of the site's complaint history found that there were no other complaints for this product.No image or video of the last procedure was provided for review.Based on the information provided at this time, this complaint is being reported based on the failure analysis findings.A tenaculum forceps instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall inside the patient.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 in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is not applicable because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.
 
Event Description
It was reported during central processing, the 8mm tenaculum forceps instrument had snapped cable.There was no report of patient involvement.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.
 
Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8mm tenaculum forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed/replicated the customer reported complaint.Failure analysis found the primary failure of a broken pitch cable to be related to the customer reported complaint.The tenaculum forceps instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.The root cause of the broken pitch cable was attributed to a component failure and related to device design.A review of the instrument log for the tenaculum forceps (470207-10/ n101903050106) associated with this event has been performed.Per logs, the tenaculum forceps was last used on (b)(6) 2021 on system sk2731.The alleged instrument had 6 uses remaining after the last procedural use.A review of the site's complaint history found that there were no other complaints for this product.No image or video of the last procedure was provided for review.Based on the information provided at this time, this complaint is being reported based on the failure analysis findings.A tenaculum forceps instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall inside the patient.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 in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is not applicable because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.
 
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Brand Name
ENDOWRIST
Type of Device
TENACULUM 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 Key13004685
MDR Text Key285837694
Report Number2955842-2021-11741
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112366
UDI-Public(01)00886874112366(10)N10190305
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 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number470207-10
Device Catalogue Number470207
Device Lot NumberN10190305 0106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Initial Date Manufacturer Received 11/19/2021
Initial Date FDA Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2019
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 Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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