MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PERMANENT CAUTERY HOOK; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420183-06

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the permanent cautery hook instrument for failure analysis.Therefore, the root cause of the customer reported failure cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the tip of the permanent cautery hook instrument broke off and fell inside the patient and was retrieved.There was no report of patient harm, adverse outcome or injury, however, it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the tip of the permanent cautery hook broke off and fell inside the patient.It was also stated that an orange flash in the yellow insulation was observed.The surgeon used a unspecified laparoscope and grasper to retrieve the broken piece during the same procedure.There was no report of patient harm, adverse outcome, or injury.Intuitive surgical, inc.(isi) made multiple follow up attempts and obtained the following additional information: the customer stated he did not recall any arcing during the procedure.The customer only witnessed an orange flash that seemed to originate from inside or behind the amber housing of the instrument.It was a few moments after when the surgeon stated that the tip seemed to be broken or not moving.The surgical assistance removed the instrument out through the trocar when the tip became dislodged from the instrument.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.Visual inspection found the instrument hook broken completely off.The piece that broke off measured approximately 0.725 and was returned with the instrument.No material was found missing, as the ceramic sleeve was returned complete.The known common cause of this failure is due to mishandling/misuse.A device history record (dhr) review for the device involved with this complaint has been completed.No non-conformances were identified to be related to this complaint.Based on the device evaluation results, this mdr report is being retracted since the failure mode was found to be due to user misuse/mishandling and not due to a malfunction of the instrument.

• Brand Name: PERMANENT CAUTERY HOOK
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6907065
• MDR Text Key: 87891044
• Report Number: 2955842-2017-00641
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-06
• Device Lot Number: M10120503 928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1