MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS

Model Number 470205-15

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

The fenestrated bipolar forceps instrument has not been returned for evaluation; 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: during a da vinci-assisted myomectomy procedure, it was alleged that a fragment broke off and fell inside the patient.Although, the fragment was retrieved and there was no report of patient harm, adverse outcome or injury, at this time it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted myomectomy procedure, one side of the ¿jaw¿ of the fenestrated bipolar forceps instrument broke off and fell inside the patient.The fragment was retrieved laparoscopically.The instrument was inspected prior to use and the surgeon confirmed there were no collisions with other instruments or hard material.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis found the instrument to have a broken grip at the distal end.The broken piece was returned with the instrument.The known common cause this failure is due to mishandling/misuse.Based on failure analysis investigation, this mdr report is being retracted as the damage to the instrument was determined to have been due to user mishandling/misuse and not due a malfunction of the instrument.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7353319
• MDR Text Key: 103171346
• Report Number: 2955842-2018-10080
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(10)N12171116
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-15
• Device Lot Number: N12171116 0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES