MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MEGA NEEDLE DRIVER; ENDOSCOPIC INSTRUMENT

Model Number 470194-04

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

The mega needle driver instrument has not been returned to isi for evaluation; therefore the root cause of the customer reported failure mode cannot be determined.A follow up mdr will be submitted if the instrument is returned, or if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted incisional hernia repair procedure, it was alleged that a fragment from the mega needle driver instrument broke off and fell inside the patient.The fragment was reported to have been retrieved during the same da vinci surgical procedure.However, the cause of the breakage is unknown.

Event Description

It was reported that during a da vinci-assisted incisional hernia procedure, a cable on the mega needle driver instrument broke and a piece of it fell inside the patient.It was confirmed that the fragment was retrieved during the same procedure with a laparoscopic instrument.There was no report of patient harm, adverse outcome or injury.On 12/12/2017, intuitive surgical, inc.(isi) followed up with the site's robotics coordinator and she stated the following: during a da vinci-assisted incisional hernia while suturing, the surgeon noticed that a cable on the mega needle driver instrument broke.She immediately tried to remove the cable with another instrument; however, in the process the cable frayed and a fragment fell inside the patient.The surgeon immediately removed the fragment with another laparoscopic instrument.The robotics coordinator confirmed that the fragment was retrieved and nothing was retained inside the patient.She also confirmed that they took an x-ray to confirm there were no fragments retained inside the patient.The instrument and cannula were inspected prior to use and it was confirmed that there were no collision of instruments during the procedure.The robotics coordinator stated that the instrument will be returned to isi for failure analysis.

• Brand Name: MEGA NEEDLE DRIVER
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7154520
• MDR Text Key: 96228646
• Report Number: 2955842-2017-00881
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112342
• UDI-Public: (01)00886874112342(10)N10170606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470194-04
• Device Lot Number: N10170606 0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65