MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP COVER ACCESSORY

Model Number 400180-14

Device Problem Arcing (2583)

Patient Problem Bowel Burn (1756)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Intuitive has received the mcs tip cover accessory associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint.The middle section of the mcs tip cover accessory exhibited localized melting, which is indicative of arcing.The site also returned the mcs instrument that is believed to have been used in conjunction with the mcs tip cover accessory.The mcs tip cover accessory was installed on the returned mcs instrument, and the position of the hole aligned with char marks found on the mcs instrument.Intuitive has received the mcs instrument associated with this complaint and completed investigations.The instrument was found to have thermal damage on the proximal clevis.The instrument was returned with an mcs tip cover accessory, and the thermal damage aligns with the thermal damage found on the instrument.The instrument was placed on an in-house system, and no arcing was observed when the energy delivery test was performed.Electrical continuity was performed and passed.Per the instruments & accessories user manual: "the endowrist monopolar curved scissors instrument is a multiple-use endoscopic instrument utilizing a single-use tip cover accessory, to be used in conjunction with the intuitive surgical endoscopic instrument control system."the intended use of the mcs tip cover accessory is as follows: "the tip cover accessory is intended to provide insulation over a section of the endowrist monopolar curved scissors instrument so that rf energy is only available at the tip." additionally, the instruments & accessories user manual provided the following general precautions and warnings: "exercise caution when working with monopolar instruments close to other instruments.Unintended energy may be delivered from the active monopolar instrument to a second instrument.This could result in burns to tissue in contact with any of the second instrument¿s metal parts or its cannula.To exercise caution in these scenarios, the monopolar tip should be closer to the tissue than to the second instrument.Warning: failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns.Warning: as with any electrosurgical device, it is possible for energy to discharge in an area other than the instrument tip.It is important to exercise caution when using an energized endowrist monopolar curved scissors instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized."warning: do not use this instrument to energize the tips of other instruments.This may damage the end effectors or injure tissue inside or outside the field of view.Tissue damage could occur at points near the tip or at the port site (cannula) of the energized instrument." a review of the system logs has been performed.There were no observed events in the system logs that would suggest a product issue, and logged events are in line with normal system functionality.This complaint will be reported due to the following conclusion: it was reported that during da vinci-assisted hysterectomy procedure, electrical energy allegedly arced through a monopolar curved scissors (mcs) tip cover accessory that was installed on an mcs instrument.According to the initial reporter, the electrical energy arced from the mcs instrument to a bipolar forceps instrument that was in close proximity.As a result of the alleged issue, the patient sustained a bowel injury that was repaired by resection.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not available.The expiration date is not applicable.Implant date is blank because the product is not implantable.Initial reporter is unknown.

Event Description

It was reported that during an unspecified da vinci-assisted surgical procedure, electrical energy allegedly arced through a monopolar curved scissors (mcs) tip cover accessory that was installed on an mcs instrument.According to the initial reporter, the electrical energy arced from the mcs instrument to a bipolar forceps instrument that was close by.As a result of the alleged issue, the patient sustained a bowel injury.On (b)(6) 2020, intuitive surgical, inc.(isi) obtained the following additional information from the site's robotics coordinator regarding the reported event: the mcs instrument arced and the patient experienced a bowel injury.As a result, the bowel was resected to repair the bowel injury.The robotics coordinator stated that he could not provide the following information: if there was instrument collision, electrosurgical unit settings, how long into the procedure the arcing was observed, the patient's ethnicity, and any relevant tests or medical history.The case was completed robotically.No further clinical information was provided.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST
• Type of Device: TIP COVER ACCESSORY
• 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: 10440870
• MDR Text Key: 203972388
• Report Number: 2955842-2020-10781
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 68