MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS

Model Number 470179

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

The instrument has not been returned to isi for failure analysis; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Based on the provided information, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that the mcs instrument broke and fragments fell inside the patient.Although, all fragments were retrieved it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted nephrectomy procedure, the customer was unable to remove the monopolar curved scissors (mcs) instrument from the arm of the da vinci system.The instrument broke past the tip of the cannula and the customer was unable to pull it back through.The customer was eventually able to remove the instrument successfully.There was no report of patient harm, adverse outcome or injury.The isi clinical sales representative (csr) later stated that the customer had mentioned that the instrument had shattered.When the instrument was removed, it was noted that a piece of the shaft was missing.The customer then compared the broken instrument to a known good instrument and confirmed that no pieces were missing.The customer confirmed that all broken fragments were retrieved from the patient.

• Brand Name: MONOPOLAR CURVED SCISSORS
• 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: 7208608
• MDR Text Key: 98197609
• Report Number: 2955842-2018-00051
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• 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: 12/27/2017

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: 470179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR