MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number 400180-14

Device Problem Material Fragmentation (1261)

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

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the monopolar curved scissors (mcs) tip cover accessory for evaluation because it was reportedly disposed of following the procedure.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.Event verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was alleged that the mcs tip cover accessory fell inside the patient during a da vinci assisted procedure.The accessory was retrieved during the same procedure via the assist port.At this time it is unknown what caused the mcs tip cover accessory to fall from the instrument and inside the patient.Follow-up was attempted, but patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.Insufficient product information was provided in order to obtain the date of manufacture.

Event Description

It was reported that during a da vinci-assisted subtotal colectomy surgical procedure, upon the removal of the monopolar curved scissors (mcs) instrument, the mcs tip cover accessory came off the instrument and fell inside the patient.The mcs tip cover accessory was removed and no harm to the patient was caused.The surgeon could not verify whether the mcs tip cover accessory was seated correctly at the start of the case.Follow-up was performed with the initial reporter and additional information was obtained.It was noted that the instrument was working fine, and was being removed from the patient so that table motion could be activated.The arm was straightened at the time, there was no reducer in use, and there was no instrument collision.There was no lubricant used when installing the accessory, and there was no resistance felt when removing the instrument through the cannula.The customer noticed that the mcs tip cover accessory had fallen off upon removal of the instrument.It was retrieved via the assist port, and another mcs tip cover accessory was installed to continue the procedure.The mcs tip cover accessory was reportedly disposed and will not be returned for analysis.The procedure was able to be completed and there was no reported patient injury.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• 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: 14191457
• MDR Text Key: 289960337
• Report Number: 2955842-2022-11240
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES