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

Model Number 400180-14

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The 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 off inside the patient.The surgical staff was able to retrieve the mcs tip cover accessory during the same surgical procedure.However, at this time, the root cause of the customer reported failure mode is unknown.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip cover accessory came off.The tip cover accessory was retrieved during the same procedure.The procedure was completed with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the clinical sales representative (csr) visited the site and confirmed that the tip cover accessory was installed correctly.The surgeon alleged that the issue may have been caused while the instrument was manipulating heavy adipose (fatty) tissue, which was particularly greasy to the eye.

• 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: 7499759
• MDR Text Key: 107839580
• Report Number: 2955842-2018-10189
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Lot Number: M11180102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• 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