MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; INSTRUMENT SHEATH

Model Number	430012-14
Medical Device Problem Codes	Flaked (1246); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer was not able to remove the single port (sp) camera instrument from the sterile adapter.The sp instrument sheaths and sp camera sheath were damaged during surgery from rubbing on the clamp of the access port, small incision (incision 3cm port placed between asis and the 12th rib), and pieces of the sheaths were flaking off into the patient.Therefore, the customer changed sheaths mid-case with minor surgery delay.The surgeon was also getting ¿instrument not moving as expected errors¿ on instruments due to excessive rubbing of shafts on access port clamp.The surgeon complained about the camera horizon indicator not actually showing them where the ground was.The surgeon also wanted more articulation in the camera or a 15 degree angled scope tip.During above cases the camera also retracted tissue up so when the camera was removed they could not reinsert it into the body with guided tool change.There was a concern that if the surgeon immersed the camera into bleeding and the camera needed to be cleaned ¿ there would be no way to reinsert the camera past the incision and the instruments would be left stuck in the body.There was also a report that the needle punctured the other instrument sheath when suturing.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the clinical development engineer mentioned that they had spoken to the surgeon extensively and all the following information was directly from the surgeon.The event was confirmed to have taken place on 06/02/2022 during a retroperitoneal ureteral implant procedure.The fragments that fell into the patient in this event were super small and the surgeon mentioned that the pieces were flakes.When the camera was pulled back, the instrument sheath flakes could be visible but were too small to retrieve.They were unsure whether the instrument/instrument sheaths were inspected prior to use.The flaking of the instrument sheath was noted to be happening throughout the surgery.This was due to the sheaths rubbing a lot with the access port clamp during the dissection of the ureter over time.There was no patient injury.Patient demographic information was not available.The sp instrument sheath had been in use for 1 hour and 40 minutes before particulate was observed in the patient.The flaking of the instrument sheath occurred during dissection of the ureter.The surgeon mentioned that they thought the instruments were rubbing the clamp ring of the small access port.The instruments were not removed from the entry guide of the access port prior to identifying the particulate of the sheath in the patient during the procedure.When the instrument was finally removed, the wrist was confirmed to have been straightened, no resistance was felt upon removal through the cannula, no damage to the cannula was noted, and there was no damage to the instrument other than the metal shaft of the instrument being exposed.The patient has not returned to the hospital experiencing any post-surgical complications.Furthermore, the surgeon said there were no patient outcome issues.The instruments/instrument sheaths will not be returned to intuitive surgical, inc (isi) for evaluation.Photographic images of the event were also provided.
Additional Manufacturer Narrative
The sp sheath has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.A follow-up mdr will be submitted if additional information is obtained.The provided image was reviewed by an isi clinical development engineer (cde).The following additional information was provided: the maryland bipolar forceps instrument was shown to be grasping a piece of the particulate.The sheath particulate was shown to be sticking to the instruments.The metal shaft of the instrument was shown to be exposed and with particulate.Possible particulate that was left in patient was observed when inserting instruments with new sheaths installed.This complaint is classified as a reportable event due to the following conclusion: it was reported pieces of the camera sheaths were flaking off inside the patient during a da vinci assisted procedure due to excessive rubbing with the clamp of the access port.The fragments were not retrieved.

• Brand Name: NONE
• Common Device Name: INSTRUMENT SHEATH
• 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: 15611831
• Report Number: 2955842-2022-14596
• Device Sequence Number: 12557461
• Product Code: NAY
• UDI-Device Identifier: 30886874114347
• UDI-Public: (01)30886874114347(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430012-14
• Device Catalogue Number: 430012
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown