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

Model Number 400180

Device Problem Melted (1385)

Patient Problem Bowel Burn (1756)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

Based on the customer's claim against the product, an investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Intuitive surgical, inc.(isi) has not received the product for evaluation.If additional information is obtained, a follow-up mdr will be submitted.Per a review of the site's system logs for the reported procedure date, no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

Event Description

It was reported that during a da vinci-assisted partial nephrectomy procedure, the tip cover accessory for the monopolar curved scissors (mcs) instrument melted, and the patient sustained minor burns in the colon, which required suturing to repair the damaged tissue.It was unknown if the burned bowel tissue was excised.It was also unknown which surgical task was being performed at the time the event occurred, however, the instrument was in use for approximately 10 minutes prior to finding that the tip cover was melted.At the time the event occurred, the prograsp forceps instrument and an unspecified bipolar instrument were also in use.The instrument tips did not collide with another instrument or tool during the procedure.When asked if the instrument tips were in contact with tissue when the arcing event occurred, there was no response.The instrument tips did not touch any staples, clips, or sutures while energized.The jaws were not immersed in liquid or contaminated by carbonized tissue prior to activating the instrument.Arcing was not observed during the procedure; it was unknown from where on the mcs instrument the energy leaked and where the arc grounded.A grounding pad was used, but when asked where it was placed on the patient, there was no response.The grounding pad did not appear to have any issues/defects.When asked which type of energy was activated when the arcing event occurred (monopolar cut / monopolar coag), there was no response.The instrument was connected properly.It was unknown which type of generator was used, however, the settings on the generator were 30 for both cut and coag.The mcs tip cover accessory appeared to be properly installed during the surgical procedure.When asked if any part of the orange surface was visible after the tip cover was installed and if the tip cover accessory was installed beyond the orange surface, there was no response.When asked if the installation tool was used or if electrolube or any other lubricant was applied to the mcs instrument prior to the tip cover installation, there was no response.The instrument was inspected prior to use, and no damage was found.The cannula was also inspected prior to use; it was unknown if a pin gauge was used to inspect the cannula.The patient has not returned to the hospital with post-operative complications.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) instrument and the mcs tip-cover accessory associated with this complaint, and a failure analysis (fa) investigation was completed.For the mcs instrument, fa replicated and confirmed the customer reported complaint, with the primary failure of thermal damage to the instrument tube extension.The instrument was found to have thermal damage on the orange tube extension at the distal end.The thermal damage aligns with the tip-cover accessory that was returned with the instrument, where the plastic was melted with a small pin hole.The instrument was placed and driven on an in-house system, where it passed the recognition and engagement tests.The instrument moved intuitively, with full range of motion in all directions on several attempts, and the scissors opened and closed properly.The instrument passed the continuity test; it released energy, and no arcing was observed.The probable root cause is attributed to mishandling/misuse.For the mcs tip-cover accessory, fa replicated and confirmed the customer reported complaint, with the primary failure of thermal damage.The distal end of the mcs tip cover exhibited localized melting with a small pin hole, 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.The mcs tip cover was installed on the returned mcs instrument, and the position of the observed hole on the tip cover aligned with the char marks found on the mcs instrument.Commonly, thermal damage to the tip-cover accessory is attributed to either improper installation onto the mcs instrument or exposure to repeated thermal and mechanical stresses during normal use conditions or collisions.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 17360706
• MDR Text Key: 319392904
• Report Number: 2955842-2023-17192
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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