MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the permanent cautery hook instrument for evaluation.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 the site's complaint history does not show any additional complaints related to this product.An image of the permanent cautery hook (pch) instrument was received from the customer.A review of the provided image was consistent with the report of a plastic piece falling off the instrument.Further details regarding the failure mode will be obtained through the failure analysis investigation upon the return of the instrument.A review of the system log and instrument log was performed.The instrument was last used on (b)(6) 2022 on system (b)(4).The permanent cautery hook has 2 uses remaining after the last use.The permanent cautery hook has a maximum of 10 uses.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a permanent cautery hook (pch) instrument broke and a plastic piece was missing.The plastic piece fell inside of the patient and the surgeon was unable to find a missing piece of ultem.It is unknown what caused the breakage to occur.Additionally, it is unknown if the fragment was retrieved or if the fragment remains inside the patient's anatomy.

Event Description

It was reported that during a da vinci-assisted hysterectomy surgical procedure, a permanent cautery hook (pch) instrument broke and a plastic piece was missing.The plastic piece fell inside of the patient and the surgeon was unable to find a missing piece of ultem.The caller indicated that the surgeon tried to find the piece but at the time of the call had not found it.The intuitive surgical, inc.(isi) technical support engineer (tse) noted that this piece was made of ultem and is not radiopaque.The surgeon was going to determine how to proceed.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: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 13565423
• MDR Text Key: 286518161
• Report Number: 2955842-2022-10306
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N10191125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N10191125 0053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• Is the Device Single Use?: No
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White