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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SMALL GRASPING RETRACTOR

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INTUITIVE SURGICAL, INC ENDOWRIST SMALL GRASPING RETRACTOR Back to Search Results
Model Number 470318-10
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
Isi received the small grasping retractor instrument involved with this complaint and completed the device evaluation. Failure analysis investigation replicated/confirmed the reported complaint. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was missing from the clevis. 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 condition, 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 was attributed to a component failure and related to device design. Additionally, the instrument was found to have various scratch marks with light material removed on the main tube. This finding was not related to the reported failure and not reported by the customer. The scratch marks were 0. 042¿ ¿ 0. 298¿ in length and were not aligned with the tube axis. The root cause of scratch marks/abrasions is typically attributed to user mishandling. 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 instrument log was performed. Per the review, the following was confirmed: device material, lot#/serial #, and event date. The instrument was last used on (b)(6) 2021 on system sk2584. The instrument had 2 uses remaining after last use. Based on the information provided at this time, this complaint is being reported due to the following conclusion: this 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 into 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.
 
Event Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, a cable on the small grasping retractor instrument was torn while grasping intestinal tissue. A similar backup da vinci instrument was used to continue with the case. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
 
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Brand NameENDOWRIST
Type of DeviceSMALL GRASPING RETRACTOR
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 Key13102078
MDR Text Key290073385
Report Number2955842-2021-11825
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Non-Healthcare 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 Number470318-10
Device Catalogue Number470318
Device Lot NumberN10210405 0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2021
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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