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

Model Number 470205-17

Device Problems Smoking (1585); Arcing (2583)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has requested the fenestrated bipolar forceps instrument for evaluation, but the instrument has not yet been received as of the date of this report. 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 for analysis and/or if additional information is received. A review of the logs showed the fenestrated bipolar forceps instrument (part# 470205-17 / lot# n11210429-0014) was last used on (b)(6) 2021 for almost 2 minutes during this reported procedure with system sk3192. The fenestrated bipolar forceps instrument has 10 allotted uses, and the alleged event occurred on its final life. In addition, a review of the site's complaint history identified no other complaints related to the fenestrated bipolar forceps instrument. No image or video clip for the reported event was submitted to isi for review. This complaint is being reported due to the following conclusion: it was alleged that the instrument arced/smoked/sparked 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. Blank mdr fields: follow-up was attempted, but the information for the patient-related fields was either unknown, unavailable, or not provided. The expiration date is not applicable. Implant date is blank because the product is not implantable. Fields pma/510k and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the customer noted that smoke was being produced at the tip of the fenestrated bipolar forceps instrument while using energy. The procedure was completed with no reported injury. On (b)(6) 2021, intuitive surgical, inc. (isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument and cannula were reportedly inspected prior to use, and no issues were noted. The customer observed arcing at the tip of the instrument. It is unknown if the conductor wire insulation was damaged; however, the customer did not see any damage to the instrument after the reported event occurred. It was noted that it was the first time the surgeon activated bipolar energy for the instrument with an external force triad generator. The surgeon was cauterizing at the time of the event; however, the instrument tips were not in contact with tissue. The monopolar curved scissors (mcs) and cadiere forceps instruments were also in use at the time of the event. The electrosurgical generator unit (esu) settings were cut 35 and coag 35. A monopolar cord was not connected to the instrument. The instrument did not collide with any other instrument or tool during the procedure. The jaws of the instrument did not come in contact with any other objects when the issue occurred. Additionally, the jaws were not immersed in a liquid or contaminated by carbonized tissue (bio debris) prior to energy activation. The instrument was not removed prior to the reported issue. The patient has not returned to the hospital due to experiencing any post-surgical complications as a result of the reported event. It was confirmed there was no patient harm, injury or adverse outcome. The instrument is available for return to isi for evaluation. No photographic images of the device or a video recording of the procedure are available.

• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13085605
• MDR Text Key: 282766764
• Report Number: 2955842-2021-11814
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: N11210429 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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: 12/26/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.