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

Model Number	470190-04
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a da vinci-assisted benign hysterectomy the cobra grasper instrument frayed during the case inside the body.There were pieces of fiber removed.The staff removed the instrument and replaced with a spare instrument.Intuitive surgical, inc.(isi) received mw5098024 on (b)(6) 2020, stating the following: "cobra instrument frayed during the case inside the body, pieces of fiber were removed.Instrument taken out and replaced." isi has made several attempts to obtain additional information from the reporter however, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cobra grasper associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the reported issue as the instrument was found to have a frayed grip cable at the distal end.Fa concluded this failure is attributed to a component failure.No image or procedure video was provided for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was observed the frayed pieces of the cobra grasper instrument fell into the patient.The frayed pieces of the fiber were removed and another instrument was used to complete the case robotically.At this time, the root cause of the reported failure is due to a component failure.

• 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: 14873797
• Report Number: 2955842-2022-12633
• Device Sequence Number: 20565302
• Product Code: NAY
• UDI-Device Identifier: 00886874112335
• UDI-Public: (01)00886874112335(10)N10190404
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: 470190-04
• Device Catalogue Number: 470190
• Device Lot Number: N10190404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2019
• 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