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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found to have a broken grip cable at the distal end.The instrument was also found to have a loose grip cable at the distal end.The instrument has a broken grip cable at the proximal end.As a result, the grip cable became loose.The instrument was found to have a grip cable dislodged in the housing at the proximal end.The dislodged cable in the proximal end caused the grip cable to be loose at the distal.The instrument was found to have a broken distal pitch cable at the distal end.The instrument was found to have an excessive amount of dried residue around the clamping pulley cable grooves.The instrument was found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley, resulting in an exposed electrode.The instrument failed the electrical continuity test.The complaint was confirmed by failure analysis.

Event Description

It was reported that during a da vinci-assisted distal pancreatectomy surgical procedure, a broken cable was noted on a fenestrated bipolar forceps instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: the fenestrated bipolar forceps were observed to have a broken piece of cable during the procedure while rotating the forceps.It was removed from the patient and a hanging piece of cable was pulled off the instrument and thrown away.No pieces were in the patient.The scrub reported the hanging piece was at the joint just off the metal tube housing and before the actual forceps.Reportedly no collisions occurred.

• 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: 18549322
• MDR Text Key: 333313380
• Report Number: 2955842-2023-22055
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(11)230727(10)K15230727(91)0006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2024
• 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: K15230727 0422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White