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

Model Number 471205-17

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.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 benign hysterectomy surgical procedure, it was observed that the plastic tip of the fenestrated bipolar forceps instrument was burnt, and there were sparks during use.The procedure was completed as planned with no reported injury using a backup instrument.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the cannula was visually inspected before use.The sparking occurred on the instrument where the sheath was melted.The bipolar energy was activated when the arcing event occurred.The instrument was correctly connected.An erbe generator/electrosurgical unit (esu) was used, with the cut setting at 4 and the coag setting at 4.The scissors and large supercut instruments along with a 30 endoscope were in use when the arcing event occurred.The jaws of the instrument did not collide with another instrument or tool during the procedure.The tip of the instrument did not touch any staples, clips, or sutures while energized.The jaws were not immersed in liquid or contaminated by charred tissue (bio-debris) before the instrument was activated.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley at the base of the grip.As a result of the damage, a section of the active electrode (grip) was exposed that would not normally be exposed.The instrument passed the electrical continuity test.A review of the procedure logs indicated that a monopolar instrument was used during this case.The complaint was confirmed by failure analysis.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR 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: 18774953
• MDR Text Key: 336175734
• Report Number: 2955842-2024-11720
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K12230615 0306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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