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

Model Number 470205-17

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint for evaluation and failure analysis was completed.Failure analysis confirmed the customer's complaint of a damaged conductor wire.The instrument was found to have damage to the conductor wire's insulation and the internal wires were visibly exposed.The instrument passed the electrical continuity test.The root cause of this failure is attributed to a component failure.Preliminary image review completed prior to the product being returned indicated that the fenestrated bipolar forceps instrument appeared to have a damaged conductor wire insulation with a potentially visible exposed wire.A review of the instrument log for the fenestrated bipolar forceps instrument lot# n10210316 / sequence 0176 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2021 on system (b)(4).The instrument had 9 remaining usable lives with no subsequent use recorded.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).This complaint is being reported based on the following conclusion: the complaint reported conductor wire damage on the fenestrated bipolar forceps instrument.A preliminary analysis of the photo provided by the customer identified what was likely conductor wire insulation damage with a potentially exposed wire without claim of ¿loss of cautery.¿ failure analysis additionally confirmed that the conductor wire had damaged insulation, wires were visibly exposed, and the instrument passed the electrical continuity test.The damaged conductor wire has potential for electrical discharge at a location other than intended.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.

Event Description

It was reported that during central processing, the customer conducted an inspection and found that the conductor wire of the fenestrated bipolar forceps instrument was damaged.There was no patient involvement.Intuitive surgical, inc.(isi) followed up with the site; however, no additional information regarding the reported event was provided.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11937335
• MDR Text Key: 254828320
• Report Number: 2955842-2021-10614
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(11)210311(10)N10210316
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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: N10210316 0176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1