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

Model Number 470400-10

Device Problem Material Separation (1562)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted ovarian cystectomy hysteroscopy surgical procedure, the long bipolar grasper instrument wire was exposed at the tip of the instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer noted they recalled the exposed wire to be black and did not know why it was exposed, however, the wire was intact.The instrument was inspected and there was no damage or anything out of the ordinary prior to use.The surgical task being performed could not be recalled.The instrument did not collide with any other instrument or tool during the procedure.The site¿s instrument cleaning or sterilization methods had not changed recently.No photographic images of the device(s) or a video recording of the procedure are available for isi review.

Manufacturer Narrative

Based on the claim against the product by the customer noting wire being exposed at the tip of the instrument, an investigation is in progress to determine the cause of this reported event.A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.Isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.The product has not been returned for evaluation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument had conductor wire exposed during a procedure.The damaged/broken conductor wire has potential for electrical discharge at a location other than intended.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.

• Brand Name: ENDOWRIST
• Type of Device: BIPOLAR GRASPER, LONG
• 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: 16942702
• MDR Text Key: 315377236
• Report Number: 2955842-2023-13666
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)K10220516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470400-10
• Device Catalogue Number: 470400
• Device Lot Number: K10220516 0061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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