MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PK DISSECTING FORCEPS

Model Number	420227-10
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, while opening the pk dissecting forceps instrument's jaws to cut tissue, a plastic piece from the pk dissecting forceps instrument broke off and fell inside the patient.The broken piece was immediately retrieved and the pk dissecting forceps instrument was removed from the field.The procedure was completed.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the instrument was inspected prior to use, and no damage was observed.Prior to the breakage, the surgeon did not notice any issues with the functionality of the instrument.The instrument did not collide with any other instruments or hard material during the surgical procedure.The fragment fell inside the patient when the surgeon was grasping the tissue.The fragment was retrieved with a laparoscopic grasper instrument.To ensure all fragments were retrieved and there were no missing pieces, the customer examined the retrieved fragment on the table.There were no post-operative tests performed to check for remaining fragments.There was no surgical procedure required to remove the fragment.The instrument was not removed prior to the breakage.Upon final removal of the instrument, the wrist was straightened.There was no resistance upon removal of the instrument through the cannula.The surgical staff did not notice any damage to the cannula.There are no photographic images of the instrument or a video recording of the procedure available for isi review.It was confirmed there was no injury to the patient.The patient has not returned to the hospital due to post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
The pk dissecting forceps instrument has been returned and evaluated by the failure analysis (fa) team.Fa investigations confirmed the customer reported complaint.The instrument was found to have a broken bipolar yaw pulley, causing the cable crimp to be exposed at the wrist of the instrument.The broken piece was missing as result of the breakage.The size of the missing piece was approximately 0.104 inch x 0.238 inch.The instrument was also found to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.No signs of thermal damage were observed on the instrument.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PK DISSECTING FORCEPS
• 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: 16927437
• Report Number: 2955842-2023-13400
• Device Sequence Number: 6756377
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N10190930
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K061260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 420227-10
• Device Catalogue Number: 420227
• Device Lot Number: N10190930 882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 102 KG