MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM FENESTRATED BIPOLARFORCEPS; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 470205-14

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

The instrument has not been returned to isi for failure analysis; 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.Based on the provided information, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, a plastic piece from the instrument broke off and fell inside the patient and was retrieved.Although no patient harm, adverse outcome or injury was reported it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, a piece of plastic from the fenestrated bipolar forceps instrument broke off and fell inside the patient.There was no report of patient harm, adverse outcome or injury.On (b)(6) 2017, intuitive surgical inc., (isi) obtained the following additional information from the initial reporter: according to the customer, the patient did not suffer any injuries as a result of this incident.The instrument was in use for about an hour before the plastic piece broke off and fell inside the patient.A laparoscopic grasper was used to remove the broken fragment.The procedure was ongoing when the fragment was identified and instruments were being exchanged for stapling when the event occurred.The piece was identified visually so it was not necessary to perform post operative test or an x-ray.The instruments were straightened during the procedure.The event was not recorded as there is no recording capability available at the institution.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported complaint.The instrument was found to have a broken yaw pulley.The yaw pulley was missing a 0.062 x 0.203 piece.This allowed the grip to move within the pulley and have a larger range of motion in the yaw.The known common cause of this failure is due to mishandling/misuse.A device history record (dhr) review for the device involved with this complaint has been completed.No non-conformances were identified to be related to this complaint.Based on the device evaluation results, this mdr report is being retracted since the failure mode was found to be due to user misuse/mishandling and not due to a malfunction of the instrument.This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.

• Brand Name: 8 MM FENESTRATED BIPOLARFORCEPS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• 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: 6889164
• MDR Text Key: 89378416
• Report Number: 2955842-2017-00627
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(10)N10161205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-14
• Device Lot Number: N10161205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1