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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI X/XI SMALL GRASPING RETRACTOR

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI X/XI SMALL GRASPING RETRACTOR Back to Search Results
Model Number 470318-10
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) investigation confirmed the reported failure. Failure analysis found the grasping retractor had a broken pitch cable at the distal end. The broken cable segment that contains the crimp was still installed in the clevis. Root cause of this failure is attributed to a component failure. Additional findings not reported by the initial reporter: the instrument was found to have various scratch marks on the main tube that measured approximately 0. 134 - 0. 164" in length and were not aligned with the tube axis. The root cause of scratch marks/abrasions on the main tube is typically mishandling. A review of the instrument log for the product associated with this event shows that the small grasping retractor was last used on (b)(6) 2021 on system (b)(4). There is no indication that the instrument was used in subsequent procedures after the alleged event reported on this record. A review of the site's complaint history does not show any additional complaints related to this product. The alleged event occurred with 7 uses remaining on the instrument. No image or video clip for the reported event was submitted for review. 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 sigmoid colectomy surgical procedure, the 8mm small grasping retractor wire snapped at the wrist. A backup of the same instrument was used to complete the procedure. There was no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the customer is unable to provide additional patient demographics and/or information.
 
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Brand NameENDOWRIST;DAVINCI X/XI
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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12223601
MDR Text Key263434585
Report Number2955842-2021-10861
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 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2021
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 NumberN10210125 0006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2021
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: 07/26/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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