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

Model Number 471172-16

Device Problem Failure to Deliver Energy (1211)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of broken conductor wire to be related to the customer reported complaint.The housing was removed for inspection and the instrument was found to have a conductor wire broken at the proximal end in the main tube.The instrument failed the electrical continuity test.No signs of thermal damage were observed at the proximal backend.There was no physical damage at the distal wrist.Root cause is attributed to manufacturing.A review of the site's complaint history does not reveal any related complaints involving this product.A review of the instrument log for the maryland bipolar forceps (part # 471172-16 /lot # n10210215-0195) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The alleged event occurred on 9th use of the instrument.There are 5 more uses left.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No image or procedure video was provided for review.This complaint is considered a reportable event due to the following conclusion: the instrument had conductor wire damage with no evidence of user mishandling or misuse.The broken 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.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted salpingectomy surgical procedure, the maryland bipolar forceps instrument had cautery issues.The procedure was completed with a back-up instrument with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and there was no visible damage.The instrument suddenly stopped working during the procedure.The instrument did not collide with any instrument or tool during the procedure.There was no thermal damage or arcing observed.The site replaced the cable without resolution.

• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12965892
• MDR Text Key: 287015117
• Report Number: 2955842-2021-11702
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)N10210215
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: N10210215 0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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 Sex: Female