MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TENACULUM FORCEPS

Model Number 470207-10

Device Problem Difficult to Remove (1528)

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

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting difficulty in removing the tenaculum forceps instrument, an investigation is in progress to determine the cause of this reported event.An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the tenaculum forceps did not close anymore, so it was impossible to remove the trocar.The robotic procedure was stopped.The procedure was aborted post anesthesia and port placement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue happened during a davinci assisted myomectomy (gynecology) surgical procedure.The procedure was aborted because the clamp was blocked in the abdomen and the removal by the trocar was impossible.The instrument jaws were blocked in open position.The surgeon believes that a material issue contributed to the complication.The trocar was uncoupled with the robot arm and the removal from abdomen was in one piece.The system was inspected prior to use and there was no issues noted during set up of the system.The procedure was in progress for approximatively 1 hour when the issue occurred.The patient did not experience post-operative complications.The instrument was inspected prior to use and there was no damage or anything out of the ordinary.Upon final removal of the instrument with the cannula, the surgical staff did feel resistance when removal was in progress.The surgical staff did not notice any damage to the cannula after the event occurred nor any other damage to the instrument after the event occurred.The port incision was not increased in order to remove the instrument and cannula together.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The tenaculum forceps instrument was analyzed, and the complaint was not replicated nor confirmed by failure analysis.Visual inspection did not reveal any damage.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The tenaculum forceps moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument released from the arm without any issues on several attempts.The instrument was fully functional.No product issue was identified.Issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.The cause cannot be determined based on the information provided and failure analysis results.No product issue was identified.The reported event was not confirmed as failure analysis of the tenaculum forceps instrument found no functional issue.The instrument was visually inspected and evaluated for its mechanical characteristics.The failure analysis investigations and in-house testing of the returned instrument revealed no issues related to the customer reported event.

• Brand Name: ENDOWRIST
• Type of Device: TENACULUM FORCEPS
• 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: 17034292
• MDR Text Key: 316292454
• Report Number: 2955842-2023-15281
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112366
• UDI-Public: (01)00886874112366(11)210722(10)K10210726
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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
• Device Operator: Health Professional
• Device Model Number: 470207-10
• Device Catalogue Number: 470207
• Device Lot Number: K10210726 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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