MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CURVED SCISSORS

Model Number 420179-15

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

The instrument will not be returned 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 (post failure analysis evaluation) or if additional information is received.The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed.No related system errors were found to have occurred during the surgical procedure.Based on the current information provided, this complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, fragments from the mcs instrument broke off and fell inside the patient.Although, all fragments were retrieved and no additional surgical intervention was required at this time it is unknown what caused the instrument breakage to occur.

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair procedure, the black band on the monopolar curved scissors (mcs) instrument allegedly broke off, fell inside the patient, and was retrieved during the same procedure.According to the initial reporter, a robotics coordinator, the mcs instrument is not available for return to intuitive surgical, inc.(isi) for evaluation.On 04-jun-2018, isi contacted the initial reporter and obtained the following information regarding the reported event: she was not present during the surgical procedure.She was informed that all fragments from the mcs instruments were retrieved and no post-operative complications have been reported.The initial report confirmed that the instrument issue was identified at the end of the surgical procedure.On 04-jun-2018, isi also contacted the isi clinical sales representative (csr) who was present during the surgical procedure.The csr indicated that the surgical staff did not notice any issues with the use of the mcs instrument during the surgical procedure.There was no resistance upon removal of the mcs instrument through the cannula.No post-operative complications have been reported to his knowledge.The csr indicated that he instructed the site to return the mcs instrument to isi for evaluation.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7575346
• MDR Text Key: 110490143
• Report Number: 2955842-2018-10265
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111505
• UDI-Public: (01)00886874111505(10)N10180208
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420179-15
• Device Lot Number: N10180208 576
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1