MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOSCOPIC ELECTROSURGICAL INSTRUMENT; TIP COVER ACCESSORY

Model Number 400180

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

The mcs tip cover accessory will not be returned for evaluation as it was discarded by the customer.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.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the mcs tip cover accessory fell inside the patient.Although, the mcs tip cover was retrieved without patient harm, adverse outcome or injury at this time it is unknown what caused the reported issue to occur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) instrument was difficult to insert into the cannula because it was allegedly very tight.When the customer removed the instrument, the mcs tip cover accessory fell inside the patient.The customer managed to recover the mcs tip cover during the same procedure.The customer installed a new mcs tip cover onto the same mcs instrument and docked with the same cannula.When trying to remove the instrument afterwards, it became stuck within the cannula.The mcs instrument and cannula had to be removed all at once.A backup cannula and mcs instrument were used to complete the procedure without any further issues and little delay.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) contacted the site and obtained the following additional information: the mcs tip cover accessory was discarded but it was not damaged.There were no issues with the cannula prior to the procedure.The mcs instrument and cannula were inspected.The surgeon never used the mcs instrument because it did not behave properly during insertion, so it was removed for additional inspection.The site does not use electrolube when installing the mcs tip cover accessory onto the mcs instrument.The tip cover was retrieved with a blue rubber device used at the site.

• Brand Name: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7582832
• MDR Text Key: 110578087
• Report Number: 2955842-2018-10271
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1