MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCED BIPOLAR

Model Number 470405-06

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided the cause of the instrument breakage that led to fatty tissue being stuck is unknown at this time.A site review was completed, and as of the date of this report, the related instrument has not been returned for analysis.No site visit was conducted.The system was working properly and no additional action was required.A follow-up mdr will be submitted if additional information is received or if the instrument is received and failure analysis is completed.Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2020.There is an emergency stop button pressed, which aligns with the irk being used on the instrument.Based on the current information provided, this complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted surgical procedure, the customer had a force bipolar instrument break at the wrist.At that time, there was tissue stuck on the wrist that had to be excised.It was confirmed that the tissue that was excised was fatty tissue and did not need any medical intervention, this does not fall under a permanent medical impairment definition.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer had a force bipolar instrument break at the wrist.At that time, there was tissue stuck on the wrist that had to be excised.The clinical sales representative (csr) informed the technical service engineer (tse) that it is believed that no fragments fell into the patient.The customer installed another force bipolar instrument and was able to complete the case.It was noted that the customer would return the instrument for analysis.The procedure was completed with no reported injury.On 03/13/2020, intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the clinical sales representative (csr) noted tha the surgeon was grasping the hernia sack with the force bipolar instrument when it broke at the wrist.The csr stated there could have been some excessive force; however, it was not clear.At the time the wrist broke, the instrument was grasping tissue and the customer attempted to use the instrument release kit (irk), but it did not work as the wrist was broken.The csr stated the surgeon had to cut the tissue around the force bipolar instrument jaws to remove the instrument.The csr confirmed that the tissue that was cut was fatty tissue and it was confirmed that there was no medical intervention rendered to the patient.The csr stated that the tissue was stuck on the base of the jaws of the instrument, the instrument was broken and the instrument release key was used and still they could not release the jaws of the instrument, hence the tissue was cut.The csr observed there was a piece of metal sticking out from the instrument, and no fragments fell into the patient.The csr informed that since the wrist was broken, a monopolar curved scissor (mcs) instrument was used to guide the force bipolar instrument out through the cannula.No post-operative tests were completed.The procedure was completed with no patient injury or harm.

• Brand Name: ENDOWRIST
• Type of Device: FORCED BIPOLAR
• 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: 9857854
• MDR Text Key: 199479003
• Report Number: 2955842-2020-10205
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470405-06
• Device Lot Number: N10200106 0170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2020
• 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