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

Model Number 470205-17

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the fenestrated bipolar forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the instrument log for the fenestrated bipolar forceps instrument lot# n10200224 / sequence 0157 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2021 on system sk2296.The alleged event occurred on the 7th use of the instrument.The instrument had 3 remaining usable lives with no subsequent use recorded.No image or procedure video was provided for review.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.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).It was reported that during central processing, inspection of the fenestrated bipolar forceps instrument identified a "torn" wire.No other issue reported.No patient involvement.Follow up information stated that the "vinyl" on the wire was torn; however, customer was unable to ascertain if it was the conductor wire.No issue was observed during the last instrument usage on (b)(6) 2021 using system sk2296.No additional information was provided.Per the event description, there is no indication that the product was not being used as intended.In general, a partial or full cable breakage occurs when the tensile load exceeds the ultimate strength of the material.Cable failure can also be caused by external collisions or other sources of damage during use or during reprocessing.A broken cable instrument will be immediately detected by a surgeon because one of the jaws stops moving and typically the end of the broken cable is visible.The instrument & accessory user manual states: ¿always have a backup instrument available to complete the surgical procedure in case of instrument failure.¿ follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 3 remaining usable lives, therefore, had not expired.Implant date is blank because the product is not implantable.Information for the blank fields in initial reporter is not available.Recall is not applicable.

Event Description

It was reported that during central processing, inspection of the fenestrated bipolar forceps instrument identified a "torn" wire.No other issue was reported and there was no patient involvement.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the customer stated the "vinyl" on the wire was torn; however, was unable to ascertain if it was the conductor wire.No issue was observed during the last instrument usage on (b)(6) 2021 using system sk2296.No additional information was provided.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D02 - intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Inspection identified insulation damage on the conductor wire located near the distal idler pulley.Material appeared to be lifted off with no material missing on the area of the damage.The known common cause of this failure is attributed to component failure.The instrument was further tested and passed electrical continuity.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11215703
• MDR Text Key: 228422427
• Report Number: 2955842-2021-10078
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(10)N10200224
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: N10200224 0157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.