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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDO WRIST 8MM, CADIER FORCEPS, IS4000

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INTUITIVE SURGICAL, INC ENDO WRIST 8MM, CADIER FORCEPS, IS4000 Back to Search Results
Model Number 471049-07
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/19/2021
Event Type  Injury  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the cadiere forceps instrument for evaluation although it has been requested for return. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. A review of system log and instrument log was performed. The instrument was last used on (b)(6) 2021 on system sk471049. The cadiere forceps had 6 uses remaining after the last use, out of 18 maximum uses. A review of the site's complaint history was performed an no other complaints related to this product were identified. No image or procedure video was provided for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a cadiere forceps instrument broke and a piece fell inside the patient. It was unknown if the instrument fragment was retrieved or if it was retained inside the patient. The root cause of the breakage also remains unknown.
 
Event Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, a cadiere forceps instrument broke and a piece fell into the patient. At the time of the call to technical support, the fragment had not been located, but the surgeon was planning to attempt to retrieve it. The site was continuing the procedure. 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.
 
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Brand NameENDO WRIST
Type of Device8MM, CADIER FORCEPS, IS4000
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 Key13023504
MDR Text Key287915355
Report Number2955842-2021-11759
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
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
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471049-07
Device Catalogue Number471049
Device Lot NumberN10210125 0035
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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