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

Model Number 470205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the fenestrated 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 an in-house system. The instrument passed the recognition and engagement tests on multiple attempts. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly. The instrument was retested and passed all testing on both attempts. The housing was removed for inspection and there was no damage found on the instrument identification board. The instrument was fully functional. The logs were unavailable at this time. Additionally, the instrument was found to have a life indicator with a failure to rotate. The housing was removed and found the life indicator did not rotate when the instrument expired. The instrument logs were unavailable at this time. The instrument was placed on an in-house system and showed the instrument had 0 use remaining. The root cause is not established. Upon visual inspection, the instrument was found to have thermal damage on the bipolar yaw pulley at the distal end. Both sides of the bipolar yaw pulley exhibited localized melting. No conductor wire insulation damage was observed on the instrument. The electrical continuity test was performed and passed. The root cause is typically attributed to mishandling/misuse. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. The system was not connected to on site, and the instrument was not registered on the system. Therefore, an instrument log review of the product related to the complaint cannot be performed at this time. Review of the images revealed no obvious damage on fenestrated bipolar forceps instrument. Based on the additional information obtained from failure analysis investigation, this complaint is being reported due to the following conclusion: the instrument was found to have thermal damage on the bipolar yaw pulley at the distal end. Both sides of the bipolar yaw pulley exhibited localized melting. No conductor wire insulation damage was observed. At this time, it is unknown what caused the thermal damage 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. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Implant date is blank because the product is not implantable. Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that prior to the start (post-anesthesia and after port placement) of a da vinci-assisted nephrectomy surgical procedure, the fenestrated bipolar forceps instrument was not being recognized after installation and showing a yellow indicator. The customer reseated the fenestrated bipolar forceps instrument and completed the procedure with no reported injury. Intuitive surgical, inc. (isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use, and no issues were noted. The issue was discovered after the customer inserted the instrument. No arcing or instrument collision were observed during the surgical procedure. A video recording of the procedure is not available, but images of the instrument were provided.

• 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: 14254856
• MDR Text Key: 290441593
• Report Number: 2955842-2022-11344
• 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

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: N11210503 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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: 04/29/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.