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.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND 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: 12369125
• MDR Text Key: 268194071
• Report Number: 2955842-2021-10995
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• 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

• 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

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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 Treatment Data

Date Received: 08/26/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.