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

Model Number 470183-14

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) followed up with the customer and was informed that the issue was resolved after the customer replaced the permanent cautery hook (pch) instrument.The pch instrument will be returned for failure analysis.Isi has not yet received the pch instrument for evaluation.Therefore, the root cause of the customer reported failure has not been determined.A follow-up mdr will be submitted if the pch instrument is returned and evaluated and/or if additional information is received.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the permanent cautery hook instrument smoked with no evidence or claim of user mishandling or misuse.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the clinical sales representative (csr) called in to report that the customer observed "smoke" coming from the wrist of the permanent cautery hook (pch) instrument as energy was applied.The surgeon was swapping back and forth between the pch and a clip applier instrument.The technical support engineer (tse) reviewed the error logs and found no issues.The tse recommended to replace the pch instrument.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the csr, who was present during the case, noted that when the customer pressed the cut function, smoke was observed coming from the tissue and the wrist of the pch instrument.However, when the coagulation function was used, no smoke was observed.The customer swapped to another pch instrument and no smoke was observed when using the cautery functions.The csr was unable to provide the lot number of the pch instrument, but was going to provide a video that was taken.The surgeon used a second pch instrument to complete the procedure.Isi contacted the operating room director and was informed that the phc instrument would be returned for analysis.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9691060
• MDR Text Key: 178501733
• Report Number: 2955842-2020-10101
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Lot Number: N10191014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES