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

Model Number 471172-16

Device Problem Smoking (1585)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the maryland bipolar forceps 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 site's complaint history does not show any additional complaints related to this product and/or this event.No image/photo was provided.The batch sequence number of the lot number was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.The maryland 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: it was alleged that the instrument smoked with no evidence or claim of user mishandling or misuse.The allegation could be related to the 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.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information for the blank fields in initial reporter name and address is not available.Fields pma/510k, adverse event, recall (if recall number is given), and correction/removal number are not applicable.

Event Description

It was reported that during a da vinci-assisted radical extraperitoneal with lymphadenectomy prostatectomy procedure, smoke appeared at the joint of the maryland bipolar forceps during the coagulation process.The procedure was completed as planned with no reported injury.Per subsequent follow-up received on 05-aug-2021, it was confirmed that the maryland bipolar instrument was checked prior to use and it was a bipolar cable that was used on the instrument.The type of generator/ electrosurgical unit that was used during procedure is not known.When the arcing event occurred, the reporter stated bipolar energy was being activated and the instruments used at that time were the scissors and cardiere forceps.It is not known if any instruments collided during the procedure or if the maryland instrument was removed any time prior to the arcing event.No further information was provided and no pictures were available for review.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Corrections can be found in field d4: lot number d03-intuitive surgical, inc.(isi) has received the maryland bipolar forceps (mbf) associated with this complaint and completed investigations.Failure analysis investigations did not replicate nor confirm the reported complaint of smoke at the instrument joint during coagulation process.When the mbf was placed and driven on an in-house system, the instrument passed the recognition and engagement tests, moved intuitively with full range of motion in all directions and the grips opened and closed properly.The mbf failed the energy delivery and electrical continuity tests.There were no signs of thermal damage at the distal end of the instrument.An additional observation unrelated to the reported complaint was found: the mbf was found to have a broken conductor wire at the proximal end.The location of the break was near the main tube/roll gear junction.Failure analysis found no signs of thermal damage.The root cause of this failure is attributed to manufacturing.A review of the instrument log for the maryland bipolar forceps instrument (part# 471172-16/ lot# n11210222 0246) associated with this event has been performed.Per logs, the maryland bipolar forceps was last used on 15-jul-2021 on system sl0521, with 11 uses remaining.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12369125
• MDR Text Key: 268194071
• Report Number: 2955842-2021-10995
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)N11210222
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: N11210222 0246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Date Manufacturer Received: 09/20/2021
• 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.; DA VINCI INSTRUMENTS AND ACCESSORIES.