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

Model Number 471405-06

Device Problem Difficult to Remove (1528)

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted inguinal hernia procedure, the staff had a force bipolar instrument that was stuck on tissue.The customer had difficulty opening jaws of the instrument.Instrument release kit would not work.The customer had to go deeper and manually release it.The staff was able to remove the instrument.The procedure was completed with no patient harm.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: customer manually opened jaws to remove the instrument.There was no patient harm and no harm to patient's tissue.No patient demographic information was available.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis could not confirm the reported issue.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests and moved intuitively with full range of motion in all directions.The grips opened and closed properly.There was no problem detected.A review of the site's complaint history does not reveal any related complaints involving this product.No image or procedure video was provided for review.Customer reported force bipolar (pn # 471405 -06 /lot # k11311206-0026) was associated with this event; however, per review of system logs for reported procedure date, logs reflect the following force bipolar instruments were used: (pn# 471405 -06/ lot# lot # k11211206-0026) and ((pn# 471405 -06/ lot# lot # k11211206-0024).Logs do not reflect that the returned instrument was used on reported procedure date.This complaint is considered as a reportable event due to the following conclusion: it was alleged that the force bipolar instrument failed to open.Medical intervention may be required in the event that the instrument fails to unclamp/release from tissue when commanded by the user or system.At this time, it is unknown what caused the unclamping event to occur.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

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

The correct lot number of the force bipolar instrument that was returned is k11211206-0026 based on system log review and confirmation from the customer that returned the instrument.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 13831646
• MDR Text Key: 297130584
• Report Number: 2955842-2022-10670
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K11211206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K11211206 0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES