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

Model Number	470171-15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations replicated/confirmed the customer reported complaint "unable to remove instrument arm from patient cart.¿ fa found the primary finding of dislodged conductor wire to be related to the customer reported complaint.The instrument was found to have a dislodged conductor wire inside the housing.The conductor wire was behind one of the release buttons which made it difficult to press.After attaching the conductor wire back to the electrical pin, the release buttons were functioning as normal.The root cause of this failure is attributed to a component failure.An additional finding not reported by the site was also identified.The instrument was found to have a broken bipolar yaw pulley.The broken piece is missing as a result of the breakage.The size of the missing piece is approximately 0.049¿ x 0.156¿.As a result of the broken yaw pulley, the grip cable crimp was dislodged.The root cause of broken instrument bipolar yaw pulley is typically attributed to mishandling/misuse, such as excess force applied to the distal end of the instrument.A review of the site's complaint history does not show any additional complaints related to this product or event.A review of the instrument log for the product associated with this event shows that the micro bipolar forceps instrument was last used on 20-dec-2021 on system sl0389.The instrument has a maximum of 10 uses.There were 9 uses remaining on the instrument.No image or video clip for the reported event was submitted for review.No additional complaints related to this event were identified in the site's complaint history.Based on the additional information obtained from failure analysis investigations, this complaint is being reported due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
Event or Problem Description
It was reported that during a da vinci-assisted beating heart revascularization (single vessel) surgical procedure , the micro bipolar forceps instrument was unable to be removed from the patient side cart (psc).The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the micro bipolar forceps instrument was inspected prior to use and no visible damage was found.The customer confirmed that the missing material/damage described in failure analysis (fa) investigation occurred outside of a surgical procedure.There were no report of fragments falling.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The instrument was able to be removed by being pried off.The procedure was almost completed, and the surgeon utilized other instruments to complete the procedure.The site¿s instrument cleaning or sterilization methods has not changed recently.The customer is unsure if there are any images available of the procedure.

• Brand Name: ENDOWRIST
• Common Device Name: MICRO BIPOLAR 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: 13648798
• Report Number: 2955842-2022-10429
• Device Sequence Number: 20326991
• Product Code: NAY
• UDI-Device Identifier: 00886874112274
• UDI-Public: (01)00886874112274(10)N10180727
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470171-15
• Device Catalogue Number: 470171
• Device Lot Number: N10180727 0070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2018
• 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: Initial
• 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