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

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)

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

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of the missing ceramic sleeve to be related to the customer reported complaint.The instrument was missing the ceramic sleeve at the distal end.The root cause could not be determined.There were additional observations not reported by the site that were not related to the customer reported complaint.The instrument was found to have scratch marks/abrasions to the distal clevis.The root cause of this failure is due to mishandling/misuse.The instrument was found to have thermal damage to the monopolar yaw pulley around the ceramic sleeve, conductor wire cap, and conductor wire¿s insulation at the distal end.The conductor wire was not exposed as a result.The instrument passed the electrical continuity test.The root cause of the thermal damage noted above is attributed to both device design and a component failure.The instrument was transferred to the advanced failure analysis team for further investigation.A review of the logs showed the permanent cautery hook instrument (part# 470183-14 / lot# n11200601-0047) was last used on (b)(6) 2021 during this reported procedure with system sk3522.The permanent cautery hook instrument has 10 allotted uses and had 3 uses remaining.In addition, a review of the site's complaint history identified no other complaints related to the permanent cautery hook instrument.A review of the provided image is consistent with the allegation of a broken "insulator" around the tip.This complaint is being reported due to the following conclusion: during a da vinci-assisted liver resection surgical procedure, it was alleged that the "insulator" around the tip of the permanent cautery hook instrument broke off and fell inside the patient.The fragment was retrieved and no additional surgical intervention was required.However, unintended fragments falling inside the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event.Furthermore, there was evidence of thermal damage proximal to the ceramic sleeve with no indication or claim of user mishandling or misuse.Thermal damage proximal to the ceramic sleeve is evidence of 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 missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration is not applicable.Implant date is blank because the product is not implantable.Fields pma/510(k) number and adverse event are not applicable.

Event Description

A peritoneal dialysis (pd) patient reported to fresenius technical support (ts) that the screen of their liberty select cycler was dim during the ready screen of treatment set-up, even though the display brightness was set to 10.The patient tried rebooting the cycler, but the screen remained dim.The ts representative issued the patient a replacement cycler.The patient was advised to notify their peritoneal dialysis registered nurse (pdrn) of the replacement.The patient was told they could continue using the cycler.The patient confirmed they have continuous ambulatory pd (capd) supplies to use if manual pd therapy was needed.There were no known patient adverse effects due to the reported issue.Additional information was requested, however, to date a response has not been received.The cycler was returned to the manufacturer for physical evaluation.Upon evaluation of the cycler by the manufacturer, an internal short was identified on the transformer of the inverter board.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, and h2.Additional product evaluation information can be found in field h10.The permanent cautery hook instrument has been evaluated by the failure analysis engineer (fae).The fae confirmed the initial failure analysis findings.

Event Description

Refer to h10/h11 for follow-up information.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.B1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

• 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: 13348746
• MDR Text Key: 284441648
• Report Number: 2955842-2022-10120
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N11200601
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N11200601 0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/04/2022; 12/22/2021
• Supplement Dates FDA Received: 03/02/2022; 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian