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

Model Number 400180

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) will not be receiving the tip cover accessory as it was discarded.Thus, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the tip cover accessory fell inside the patient.Although, the tip cover was retrieved and no patient harm, adverse outcome or injury was reported, it is unknown what caused the accessory to fall inside the patient.

Event Description

It was reported that at the end of a da vinci-assisted low anterior resection procedure, as the customer undocked the system and removed the monopolar curved scissors (mcs) instrument, the msc tip cover accessory was missing.The surgeon believed the tip cover accessory got stuck in the cannula as the instrument was removed.The surgeon then introduced an unspecified grasper instrument through the cannula and the tip cover accessory fell inside the patient.The tip cover accessory was immediately retrieved, inspected and confirmed it was intact.The procedure was completed and there was no report of harm, adverse outcome or injury.The tip cover accessory was discarded by the customer.

• Brand Name: TIP COVER ACCESSORY
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ACCESSORY
• 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: 6826930
• MDR Text Key: 83875369
• Report Number: 2955842-2017-00579
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• 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?: No
• Date Manufacturer Received: 08/10/2017
• 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: Initial
• Patient Sequence Number: 1