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

Model Number 471405-06

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of the damaged conductor wire insulation to be related to the customer reported complaint.The force bipolar instrument was found to have damage to the conductor wire¿s insulation at the distal end and the conductor wire was exposed as a result.The instrument passed the electrical continuity test and had no signs of thermal damage observed.The root cause of this failure is attributed to a component failure.A review of the instrument log for the force bipolar (471405-06/ n10210510-0071) associated with this event has been performed.Per logs, the force bipolar instrument was last used on (b)(6) 2021 on system sk4222.The instrument had 1 use remaining after the last procedural use.A review of the site's complaint history does not show any additional complaints related to this product.No image or video of the last procedure was provided for review.This complaint is being reported due to the following conclusion: during failure analysis testing, the force bipolar instrument was found to have conductor wire damage with exposed internal wires and a passed 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.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is not applicable because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.

Event Description

It was reported that during a da vinci-assisted procedure, the 8mm force bipolar instrument wire popped off and the instrument tip broke.The device was not used on the patient and the procedure was completed.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of the damaged conductor wire insulation to be related to the customer reported complaint.The force bipolar instrument was found to have damage to the conductor wire¿s insulation at the distal end and the conductor wire was exposed as a result.The instrument passed the electrical continuity test and had no signs of thermal damage observed.The root cause of this failure is attributed to a component failure.A review of the instrument log for the force bipolar (471405-06/ n10210510-0071) associated with this event has been performed.Per logs, the force bipolar instrument was last used on (b)(6) 2021 on system sk4222.The instrument had 1 use remaining after the last procedural use.A review of the site's complaint history does not show any additional complaints related to this product.No image or video of the last procedure was provided for review.This complaint is being reported due to the following conclusion: during failure analysis testing, the force bipolar instrument was found to have conductor wire damage with exposed internal wires and a passed 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.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is not applicable because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.

Event Description

It was reported that during a da vinci-assisted procedure, the 8mm force bipolar instrument wire popped off and the instrument tip broke.The device was not used on the patient and the procedure was completed.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 13011814
• MDR Text Key: 285742407
• Report Number: 2955842-2021-11750
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)N10210510
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: N10210510 0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 37 KG