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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST MEDIUM-LARGE CLIP APPLIER

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INTUITIVE SURGICAL, INC ENDOWRIST MEDIUM-LARGE CLIP APPLIER Back to Search Results
Model Number 470327-12
Device Problem Unintended System Motion (1430)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the medium large clip applier instrument and completed the failure analysis testing. The customer allegation of the tip being loose and moving in an unintended direction was not able to be replicated or confirmed through testing. The instrument did not exhibit a loose grip tip. The instrument was placed and driven on an in-house system and it moved intuitively in all directions. The clip test was performed and passed without any issues. The root cause of the customer's reported issue cannot be traced to the device. 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 for the medium-large clip applier instrument lot# n10191007 / sequence 0074 associated with this event has been performed. Per logs, the instrument was last used on the reported event date of (b)(6) 2021 on system sk1529. The instrument has 71 remaining usable lives with no subsequent use recorded. No procedure video or image was submitted to isi for review. This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the clip applier instrument moved with unintuitive motion (e. G. The instrument unexpectedly jerked/jumped/swung/bowed, moved in an unexpected/unintended/unknown way). Unintuitive motion could lead to subsequent tissue damage. 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 colorectal procedure, the user observed that the clip from the medium large clip applier instrument tip appeared to be "loose" and moved unintuitively.
 
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Brand NameENDOWRIST
Type of DeviceMEDIUM-LARGE CLIP APPLIER
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 Key13115255
MDR Text Key289961374
Report Number2955842-2021-11832
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 Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470327-12
Device Catalogue Number470327
Device Lot NumberN10191007 0074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2021
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/03/2019
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 Treatment Data
Date Received: 12/29/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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