MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA NEEDLE DRIVER

Model Number 470194-06

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); No Apparent Adverse Event (3189)

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

Event Date 03/07/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the mega needle driver instrument had a tip bent and remained plugged into the dryer.The procedure was completed with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the mega needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint of ¿tip bent¿.Failure analysis found the primary failure of instrument proximal clevis broken to be related to the customer reported complaint.The instrument was found to have the plastic proximal clevis broken.The broken piece was not missing as a result of the breakage.This failure is typically attributed to mishandling/misuse.Additional observation(s) not related to the customer reported complaint: the instrument was found to have a broken distal pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The instrument was also found to have a broken grip cable at the distal idler pulley.The distal idler pulley spun freely and did not exhibit any damage.

• Brand Name: ENDOWRIST
• Type of Device: MEGA NEEDLE DRIVER
• 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: 17244368
• MDR Text Key: 318568969
• Report Number: 2955842-2023-16764
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112342
• UDI-Public: (01)00886874112342(11)220714(10)K10220714
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K150284
• 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
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470194-06
• Device Catalogue Number: 470194
• Device Lot Number: K10220714 0199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 07/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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