MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PERMANENT CAUTERY SPATULA; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420184-06

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

The permanent cautery spatula instrument has not been returned to isi for failure analysis 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 (post engineering evaluation) or if additional information is received.Intuitive surgical, inc.(isi) has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, a pin from the permanent cautery spatula instrument fell inside the patient.While the pin was retrieved, recurrence of the reported failure mode could likely cause or contribute to an adverse event.It is unknown what caused the reported issue.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy procedure, a piece of the plastic at the distal end of the permanent cautery spatula instrument broke off and fell inside the patient.The broken fragment was retrieved without patient harm.On july 18, 2017, intuitive surgical, inc.(isi) received additional information from the isi clinical sales representative (csr) who initially reported this complaint.According to the isi csr, the surgeon was cauterizing unspecified tissue, when it was observed that a pin from the permanent cautery spatula instrument had fallen into the patient.The pin was retrieved laparoscopically from the patient with the da vinci surgical system.The planned surgical procedure was completed and there was no harm to the patient.According to the csr, there was no observed force placed on the instrument and it is unknown what caused the pin to fall into the patient.

• Brand Name: PERMANENT CAUTERY SPATULA
• Type of Device: ENDOSCOPIC ELECTROSURGICAL 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: 6740808
• MDR Text Key: 80947520
• Report Number: 2955842-2017-00492
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420184-06
• Device Lot Number: M11130503 550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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