MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MONOPOLAR CURVED SCISSORS

Model Number 470179-19

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) instrument was analyzed.The instrument was found to have a broken tube extension at the distal end.No pieces were missing.Additionally, the instrument was found to have the main tube broken.No material was found missing.The complaint was confirmed by failure analysis.A review of the provided image was consistent with the reported failure of physical damage to the tube.

Event Description

It was reported that during a da vinci-assisted radical hysterectomy surgical procedure, the wrist base of the monopolar curved scissors (mcs) was broken off after a collision with another instrument.The mcs instrument was stuck in the cannula.It was confirmed that the mcs was inspected prior to use with no issue.No fragment fell inside the patient.There was no arcing during the procedure.The procedure was completed.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the mcs instrument wrist base was not completely detached from the instrument shaft.The instrument was removed together with the cannula.The surgeon had to perform port incision enlargement to remove the instrument.No post-operative tests were performed.There was no unexpected bleeding due to port incision enlargement.There was no concern about this event causing any long-term complications with the patient.The patient did not experience any post-operative complications and did not return to the hospital due to any post-surgical complications.There was no fragment that fell into the patient¿s anatomy.The procedure was not delayed.The customer used a backup instrument to complete the procedure.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 18360752
• MDR Text Key: 330932848
• Report Number: 2955842-2023-21377
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112298
• UDI-Public: (01)00886874112298(11)230427(10)K16230427(91)0107
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K220023
• Number of Events Reported: 1
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470179-19
• Device Catalogue Number: 470179
• Device Lot Number: K16230427 0440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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 Sex: Female