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

Model Number 471172-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/12/2022

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 did not replicate nor confirm the customer reported complaint. The instrument was placed and driven on a test system. The instrument passed the recognition and engagement tests. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly. The instrument was fully functional. Additional steps/test attempts to further support non reproducible finding: the housing was removed from the back end, no damage was found. An electrical continuity test was performed and passed. An energy test was performed while the instrument was installed on a test system and passed. Review of the logs found no failures related to the reported instrument. There was no problem detected for the customer reported complaint. An additional observation not reported by the site was also identified. The instrument was found to have thermal damage on the bipolar yaw pulley. The yaw pulley showed signs of charring and localized melting at the base and on the exterior of the grips. The thermal damage to the yaw pulley is unrelated to the conductor wire on the instrument. No insulation damage was observed. The conductor wire is not damaged or broken. The root cause for this failure is attributed to mishandling /misuse, commonly caused by collision with another energized instrument. A review of the instrument log for the maryland bipolar forceps instrument (pn# 471172-16 / lot# k10210624-0073) associated with this event has been performed. Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 19 seconds. The alleged event occurred on the 3rd use of the instrument. There is no indication that the instrument was used in subsequent procedures after the alleged event reported on this record. A review of the site's complaint history does not show any additional complaints related to this product. No image or video clip for the reported event was submitted for review. This complaint is considered a reportable malfunction due to the following conclusion: the instrument had thermal damage on the bipolar yaw pulley. Although there was no arcing reported by the customer, the thermal damage is potentially indicative of stray energy. 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

It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the maryland bipolar forceps instrument was not receiving input from the surgeon side console to open the instrument jaws. A backup instrument of the same type was used and the procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the customer and obtained the following additional information. The customer stated the instrument was not inspected prior to use; but also noted that no damage or anything out of the ordinary was identified. The grips never opened and the instrument was never reseated or reinstalled. The instrument was not clamped on tissue and the instrument release kit (irk) was never used. No injury was reported. The instrument is being returned to isi for evaluation. No photographic images or video are available to 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14275197
• MDR Text Key: 290642737
• Report Number: 2955842-2022-11390
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: K10210621 0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 05/04/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES