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

Model Number	470405-06
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a force bipolar instrument broke while in use within the patient.The fragment fell while removing mesh from the patient.The fragment was retrieved with a backup instrument during the same procedure.The fragment was available for return.The procedure was completed with no reported patient impact.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details had been received as of date of this report.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The force bipolar instrument was analyzed, and failure analysis (fa) was able to replicate and confirm the reported issue.The instrument was found to have a broken grip at the midpoint of the grip.The broken piece was still attached to the instrument by the conductor wire.This damage may be attributed to either device design or use conditions.Regarding device design, fragments can result as retention of the metal injection molding (mim) to the overmold (om) is insufficient.Regarding use, damage to the force bipolar instrument can occur while performing ¿off-label¿ surgical applications, such as needle bending/driving and suture snapping, mishandling the instrument causing collisions, and misusing the instrument.An additional observation(s) made that was not reported by site.The instrument was found to have an excessive amount of dried residue around the clamping pulley cable grooves.The complaint was confirmed based on failure analysis, which indicates that the device did contribute to the customer-reported issue.

• Brand Name: ENDOWRIST
• Common Device Name: FORCE BIPOLAR
• 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: 17136607
• Report Number: 2955842-2023-16353
• Device Sequence Number: 14426426
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)K10210830
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K180351
• 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
• Report Date (Section B): 05/22/2023

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: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: K10210830 0153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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 Sex: Unknown