MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 420183-12

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/30/2019

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the tip of the permanent cautery hook instrument was found to be melted.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on 14-jan-2022 and obtained the following additional information: the issue was identified during the procedure.The instrument was inspected before use and no damage was noticed.The instrument was also inspected after use and prior to reprocessing.No damage was noticed after the procedure.No arcing was observed during the procedure.The instrument did not collide with any other instrument or tool during the procedure.The procedure was completed with a backup instrument.No patient was harmed as a result of the issue.No fragment fell into the patient.The operation was not prolonged due to the issue.

Manufacturer Narrative

Isi has not received the permanent cautery hook instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the instrument (pn 420183-12/lot # n1180426 688) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2019 on system usg237.The instrument had 6 uses remaining after last use.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.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 not applicable because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Manufacturer Narrative

Isi has not received the permanent cautery hook instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the instrument (pn 420183-12/lot # n1180426 688) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2019 on system usg237.The instrument had 6 uses remaining after last use.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.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 not applicable because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the tip of the permanent cautery hook instrument was found to be melted.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on 14-jan-2022 and obtained the following additional information: the issue was identified during the procedure.The instrument was inspected before use and no damage was noticed.The instrument was also inspected after use and prior to reprocessing.No damage was noticed after the procedure.No arcing was observed during the procedure.The instrument did not collide with any other instrument or tool during the procedure.The procedure was completed with a backup instrument.No patient was harmed as a result of the issue.No fragment fell into the patient.The operation was not prolonged due to the issue.

Manufacturer Narrative

D01/d02/d03/d11: intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported complaint.The instrument was found to have thermal damage on the monopolar yaw pulley.The thermal damage was located at the ceramic sleeve.The electrical continuity test was performed and passed.The ear of the distal clevis was cut in-house to inspect arcing.No weld damage was observed.The root cause is attributed to a device design.The instrument was also found to have thermal damage on the distal clevis.The thermal damage was located near the ceramic sleeve and at the distal idler pulley.The root cause is attributed to a component failure.The instrument was also found to have a dislodged ceramic sleeve.The root cause is attributed to manufacturing.Upon inspection, the ceramic sleeve also appeared to be broken.Broken pieces were missing as a result of breakage.The size of the missing pieces was approximately 0.020¿ x 0.038¿.The root cause is typically attributed to user mishandling, such as excessive force applied to the distal end of the instrument or accidental collisions.Additionally, the instrument was found to have indentations on the edges of the distal idler pulleys.The root cause is typically attributed to user mishandling, such as instrument collisions or impact from an external object.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 13475874
• MDR Text Key: 285212653
• Report Number: 2955842-2022-10189
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10180426
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-12
• Device Catalogue Number: 420183
• Device Lot Number: N10180426 688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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.