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

Model Number 420205-16

Device Problems Electrical /Electronic Property Problem (1198); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

Isi has received the fenestrated bipolar forceps instrument involved with this complaint, but analysis has not been completed.A review of the instrument log for the fenestrated bipolar forceps instrument associated with this event confirmed that the instrument was last used on 05/14/2020 on system sh2135.Logs confirmed that the instrument had 5 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A photographic image of the device was provided by the customer and reviewed by the failure analysis engineering (fae) team.Based on the image, the conductor wire appeared to be improperly crimped within the base of the grips.There was no missing conductor wire insulation material identified in the photo.However, the exposed wire is meant to be held within the base of the grips underneath the yaw pulley, not exposed outside of the grip-crimp.Once failure analysis investigation is completed or if additional information is obtained, a follow-up mdr will be submitted.The fenestrated bipolar forceps instruments are multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).Based on the information provided at this time, this complaint is being reported because: after a da vinci-assisted surgical procedure, it was noted that the coat of the fenestrated bipolar forceps instrument conductor wire peeled off.Based on this finding, it was concluded that a fragment may have fallen inside the patient and was not found.A review of the image provided by the customer indicated that no coating appeared to be missing from the wire.However, the product has not been analyzed yet to confirm whether any fragment is missing.Although there was no report of patient injury, unintended fragment(s) falling into the patient may require surgical intervention.At this time, the location of the potentially missing fragment is unknown and it is unclear if a fragment actually fell inside the patient and was retained.In addition, the root cause of the customer reported failure mode is unknown.

Event Description

It was reported that after a da vinci-assisted surgical procedure, the coat of the fenestrated bipolar forceps instrument conductor wire was noted to have peeled off.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was unknown whether any fragments fell inside the patient during the procedure.No injury occurred to the patient.There was no video recording of the procedure available for isi review.The customer was unwilling to provide information about the patient's medical history or the patient demographic information.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in sections g4, g7, h2, h3, h6, and h10/h11.Corrected data based on new information can be found in sections b1, h1, h6, h10/h11.4307 - intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation replicated/confirmed the customer reported complaint.A visual inspection of the instrument was performed and the insulation of the conductor wire was found to be dislodged from its correct position at the yaw pulley of the distal end.The instrument passed the electrical continuity test.No signs of thermal damage were observed and no material was found missing.Based on the current information provided, this complaint remains reportable due to the following conclusion: a bipolar instrument with damaged conductor wire insulation could lead to inadvertent energy transmission to tissue other than intended via the exposed conductor wire.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10317206
• MDR Text Key: 202216794
• Report Number: 2955842-2020-10679
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10191111
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-16
• Device Catalogue Number: 420205
• Device Lot Number: N10191111 734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Other