MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BIPOLAR GRASPER, LONG

Model Number	470400-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, an insulation piece came off the long bipolar grasper instrument.The piece did fell off into the patient and was retrieved.The issue was identified intraoperatively.A backup instrument was used.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it is unknown if the long bipolar grasper instrument was inspected prior to use.The surgical task being performed was dissection.The instrument was in use for 30 minutes.The procedure was subsequently converted to open surgery unrelated to instrument issue.The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure.The instrument was not observed to collide with any other instruments or other hard material during the surgical procedure.The fragment(s) did not fall inside the patient during an instrument tip / accessory collision.The surgical staff did not feel any resistance upon removal of the instrument through the cannula.The surgical staff did not notice any damage to the cannula after the event occurred.The surgical staff did not notice any other damage to the instrument after the event occurred.The fragments were retrieved with an assistance of lap grasper and all the fragments were retrieved.No additional surgical procedures were required to remove fragments.No post-operative tests were done.The procedure delay was less than 3 minutes.The procedure was converted to open due to patient anatomy.It was converted due to inability to progress due to difficult anatomy.The specific issue with the patient anatomy that led to the surgeon¿s decision to convert to open surgery was a non-compliant lung and it was difficult to see target anatomy.During timeout before procedure the surgeon communicated to the room there was a strong possibility the procedure may convert to open due to challenging anatomy.The patient did tolerate the change and there was no patient impact.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting a piece fell off, an investigation is in progress to determine the cause of this reported event.A return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Isi has received the product, and the failure analysis investigation is in progress.A follow-up mdr will be submitted post-failure analysis evaluation, or if additional information is obtained.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The long bipolar grasper instrument was analyzed and the reported issue was replicated and confirmed.The instrument was found to have a broken bipolar yaw pulley.A broken piece approximately 0.140¿ x 0.080¿ was missing as a result of the breakage and was not returned.This failure is most commonly attributed to mishandling.An additional observation not reported by the site was also identified.The instrument was found to have a severely bent grip, causing side to side misalignment of the grips.There was a 0.143¿ offset at the tips.The cause of this failure is typically attributed to mishandling.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Corrected/additional information available in section a.

• Brand Name: ENDOWRIST
• Common Device Name: BIPOLAR GRASPER, LONG
• 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: 17190058
• Report Number: 2955842-2023-16545
• Device Sequence Number: 5785303
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10170927
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2023

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
• Operator of Device: Health Professional
• Device Model Number: 470400-07
• Device Catalogue Number: 470400
• Device Lot Number: N10170927 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 09/08/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/11/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic