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

Model Number	470190-04
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	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the cobra grasper broke while being used for extracting tissue.There was no report of fragments falling inside the patient.The procedure was completed with a backup da vinci instrument of the same kind, and there was no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain the information regarding patient demographics, relevant testing, and medical history; however, the reporter was not able to provide that information.No further details were provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cobra grasper instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint of "the instrument was broken." the instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.The root cause of the broken pitch cable was determined to be a component failure and related to device design.A review of the instrument log for the cobra grasper (part # 470190-04/ lot # n10180816 0047) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021, on system (b)(4).The instrument had 5 uses remaining after last use.In addition, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted to isi for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

• Brand Name: ENDOWRIST
• Common Device Name: COBRA GRASPER
• 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: 12850101
• Report Number: 2955842-2021-11559
• Device Sequence Number: 11965932
• Product Code: NAY
• UDI-Device Identifier: 00886874112335
• UDI-Public: (01)00886874112335(10)N10180816
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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: 470190-04
• Device Catalogue Number: 470190
• Device Lot Number: N10180816 0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2018
• 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: 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: Female