MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MARYLAND DISSECTOR

Model Number	420143-07
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the maryland dissector instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the maryland dissector instrument (lot # t10200521 / sequence #146) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system sh2350.The instrument has 5 remaining usable lives with no subsequent use recorded.No image or procedure video was provided for review.This complaint is being reported due to the following conclusion: it was alleged that the maryland dissector instrument jaws failed to open during a procedure.Medical intervention may be required in the event that the instrument fails to unclamp/release from tissue when commanded by the user or system.At this time, it is unknown what caused the unclamping event to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted thyroid resection surgical procedure, the user observed that the maryland dissector instrument was unable to open its jaws.Instrument was removed and manual rotation of the input disks confirmed the issue.The user completed the procedure using the backup instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the instrument was inspected by the hospital nurse prior to use.The instrument initially worked; however, suddenly found it inflexible and the jaws can¿t be opened manually.The instrument was not involved in any known collision or contact with a hard object.The maryland dissector instrument was grasping the thyroid tissue at the time of the issue (unable to open the jaw).No other information as to how the instrument jaws were opened and release the thyroid was provided.The tissue was released and no additional intervention was performed.No damage to the thyroid confirmed.
Additional Manufacturer Narrative
Failure analysis information can be found in h6 and h10.D02 - intuitive surgical, inc.(isi) received the maryland dissector instrument involved with this complaint and completed the device evaluation.Failure analysis investigation identified that the grip input disk spun freely without corresponding output motion at the distal end, suggesting a failure at the backend.The instrument housing was removed and inspection found a loose grip cable at the backend.As a result, intuitive motion was not being experienced at the snake wrist assembly.This observation is attributed to a component failure.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MARYLAND DISSECTOR
• 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: 13561191
• Report Number: 2955842-2022-10285
• Device Sequence Number: 17218209
• Product Code: NAY
• UDI-Device Identifier: 00886874111413
• UDI-Public: (01)00886874111413(10)T10200521
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 420143-07
• Device Catalogue Number: 420143
• Device Lot Number: T10200521 146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• 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