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

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.

• Brand Name: ENDO WRIST
• Type of Device: 8MM, 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 Key: 13023504
• MDR Text Key: 287915355
• Report Number: 2955842-2021-11759
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119778
• UDI-Public: (01)00886874119778(10)N10210125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• 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 Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471049-07
• Device Catalogue Number: 471049
• Device Lot Number: N10210125 0035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2021
• 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 Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES