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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 470327-09
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted low anterior resection procedure, the medium large clip applier instrument malfunctioned and exhibited non-intuitive movement. Troubleshooting was performed by replacement of the instrument to the backup and this resolved the issue. The user completed the procedure with no further issue reported. No fragment fell inside the patient. No known impact or patient consequence was reported. Intuitive surgical, inc. (isi) followed up with the site and obtained the following additional information regarding the reported event: customer was unable to confirm if the instrument and accessory was inspected prior to use. At the time of the issue, the instrument jaw motion did not match the action intended by the surgeon. Each occurrence happened with the same instrument on the same system arm. The sterile instrument arm drape was not exchanged at any time during the procedure. The issue was intermittent.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the medium large clip applier instrument for evaluation. The reported event was not confirmed through failure analysis investigation. The instrument was tested with an in-house system and passed both the engagement and self tests. Testing found the instrument exhibiting intuitive motion in all directions with the grips properly opening and closing. The instrument functionality was verified and passed specification including the bumper and clip tests. The instrument operated as expected. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No procedure video or image was submitted to isi for review. A review of the instrument log for the medium-large clip applier instrument lot# n10181011 / sequence (b)(4) 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 (b)(4). The instrument has 14 remaining usable lives with no subsequent use recorded. This complaint is considered as a reportable malfunction due to the following conclusion: it was alleged that the clip applier instrument moved with unintuitive motion (e. G. The instrument moved in an unintended 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.
 
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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 Key13040260
MDR Text Key284367013
Report Number2955842-2021-11776
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
Report Date 11/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470327-09
Device Catalogue Number470327
Device Lot NumberN10181011 0090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2021
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2018
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: 12/19/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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