MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; SMALL GRASPING RETRACTOR

Model Number	420318-05
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	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the small grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint of 'broken/loose cable'.Failure analysis found the primary failure of broken/loose cable to be related to the customer reported complaint.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.Root cause of this failure is attribute to a component failure.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 small grasping retractor (part # 420318-05 /lot # n10181114 - 011) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2020 on system rsh0252.The alleged event occurred on the 2nd use of the instrument.There are 8 more uses remaining.A review of the site's system logs for the reported procedure date was conducted by.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.The small grasping retractor instruments are multiple-use endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system.The instrument is designed to grab, manipulate, retract, and dissect tissue during a da vinci assisted surgical procedure.Based on the information obtained from failure analysis investigations, 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.While there was no harm or injury to the patient, the reported failure mode could 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 adrenalectomy surgical procedure, the small grasping retractor instrument cable broke.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11324464
• Report Number: 2955842-2021-10131
• Device Sequence Number: 14286781
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10181114
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 420318-05
• Device Catalogue Number: 420318
• Device Lot Number: N10181114 011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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