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 Type  malfunction  

Manufacturer Narrative

The tip cover accessory nor the instrument will be 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 or accessory are returned (post engineering evaluation) 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 accessory was retrieved and no patient harm, adverse outcome or injury was reported, it is unknown what caused the tip cover accessory to fall inside the patient.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the surgeon noted that the tip cover accessory was inside the patient.The tip cover accessory was retrieved with a laparoscopic grasper during the same da vinci surgical procedure.The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported.Intuitive surgical, inc.(isi) followed up with the customer and obtain the following additional information: the customer confirmed that procedure was completed robotically and the fragment was retrieved during the same procedure without patient harm.Furthermore, it was confirmed that both the monopolar curved scissors (msc) instrument nor the tip cover accessory will be returned to isi for evaluation.The customer was not able to confirm the date of the event.

• 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: 7492711
• MDR Text Key: 107716990
• Report Number: 2955842-2018-10183
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/12/2018

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: 400180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/07/2018
• 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: N
• Patient Sequence Number: 1