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

Model Number 400180

Device Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the monopolar curved scissors (mcs) tip cover accessory for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.Verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log.Images of the mcs tip cover accessory related to this event were received.A review of one of the submitted images was performed by an isi failure analysis engineer (fae).The following additional information was provided: in taking a closer look, damage can be seen on the cover accessory near the dark spots.Damage in this form (scratches/gouges) can be caused by collisions between instruments or other hard surfaces.The dark spots look like they could be thermal damage and could be caused by arcing between instruments, a possible result of activating energy near another instrument in combination with the tip cover being damaged.Root cause of the failure mode cannot be confirmed without the returned device.This complaint is being reported due to the following conclusion: it was alleged that after a da vinci-assisted procedure, the intuitive surgical (is) clinical sales associate (csa) and the customer had observed some thermal damage to the monopolar curved scissors (mcs) tip cover accessory.It is unknown what caused the damage.In the event the tip cover is compromised, it is possible for energy to discharge in an area other than the instrument tip.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.Device manufacture date is blank because insufficient product information was provided in order to obtain the date of manufacture.

Event Description

It was reported that after a da vinci assisted surgical procedure, the intuitive surgical, inc.(isi) clinical sales associate (csa) and the customer had observed some thermal damage to the monopolar curved scissors (mcs) tip cover accessory.They are unsure whether this was user error however, the cover had slipped for some of the operation and this wasn't corrected so may have been user error.The procedure was completed with no report of patient harm, adverse outcome or injury.On (b)(6) 2022 and (b)(6) 2022 isi contacted the site and obtained the following additional information regarding this event: the instrument was inspected prior to use and there was no damage noticed.There is no patient injury and patient has recovered and discharged and doing well.The surgeon is not aware of any fragment falling into the patient during the procedure.The defect on the instrument was noticed at the end of surgery.No backup instrument was needed.The operation was not prolonged due to this issue.Arcing was not observed.No damage to the instrument/accessory was noted after the arcing event.Surgery was complete when the arcing event occurred.A monopolar cord was not connected to a bipolar instrument.The settings used on the generator/electrosurgical unit (esu) were cut: 30, coagulation: 30.The instrument tips did not collide with any other instrument or tool during procedure and did not touch any staples, clips or sutures while energized.The jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.The instrument was not removed at any time prior to arcing, and the wrist is always straightened during removal.The surgeon does not know what caused the arcing event.The patient did not experience any intra-operative complications.Only one tip cover accessory was used throughout surgery.The tip cover did not slip a little on the instrument shaft, did not fell and surgeon stated this has not happened before in any of her cases.Tip cover accessory is available for return to is for evaluation.No patient information was provided.On (b)(6) 2022, isi contacted the reporter to obtain additional information regarding this event.However, no additional details have been received as of the date of this report.

• 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: 15375455
• MDR Text Key: 299439822
• Report Number: 2955842-2022-13891
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2022
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.