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

Model Number 471405-06

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

It was reported during a da vinci-assisted benign hysterectomy procedure, the force bipolar instrument would not come out of the trocar and wires from the instrument broke.The customer used the instrument release key (irk) to remove instrument.The customer advised that nothing fell into patient.The site replaced the instrument and completed the procedure as planned with no report of patient injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

The force bipolar instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) 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.No image or procedure video was provided for review.A review of the instrument log for the force bipolar instrument (471405-06/ n11210628-0115) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2022 during a malignant hysterectomy procedure performed via system serial# (b)(4).This complaint is being reported based on the following conclusion: it was alleged that the force bipolar instrument could not be removed from the cannula due to the loose cable.Jaw dislodgment could result in the tips being stuck and unable to be opened with mtm activation or instrument release kit (irk) use.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 while grasping tissue.Medical intervention may be required in the event that the instrument jaws fail to open from tissue when commanded by the user or system.At this time, it is unknown what caused the grip/hinge to become dislodged.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 14116528
• MDR Text Key: 291500297
• Report Number: 2955842-2022-11055
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)N11210628
• Combination Product (y/n): N
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: N11210628 0115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female