MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER SHEATH

Model Number	410370-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a da vinci-assisted procedure the stapler sheath fell inside the patient's anatomy while removing the stapler from the patient.The staff retrieved the fragment from the patient during the same procedure and the case was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the robotic surgery manager and obtained the following additional information: the robotic surgery manager said the reported incident occurred during a robotic thoracoscopy for lobectomy procedure.It was noted the stapler sheath and the stapler instrument were inspected prior to use and no damage was observed.Prior to the stapler sheath falling into the patient, it was noted the instrument and accessory had been fired 6 times.At the time the customer observed the stapler sheath tear, the wrist was slightly flexed during the removal of the instrument, and the assistant noticed a small tear on the sheath.It was stated that the assistant thought it would be okay to keep using the stapler sheath.The first assist informed the robotic surgery manager that the instrument was more difficult to remove than usual.The stapler instrument was then re-inserted, and the small tear caught onto the cannula and tore off completely.The first assistant retrieved the stapler sheath via the air seal port.The surgeon confirmed visually that all fragments were retrieved.No addition surgery nor post-op test were required.The robotic surgery manager informed that no instrument collisions were observed nor damage to the cannula were noted.The customer continues using a stapler 30 instrument to continue the case.No video/image was available for review.The stapler sheath accessory was not available for return.The procedure was completed robotically with no patient injury or harm.
Additional Manufacturer Narrative
The product involved with this event was requested to be returned for analysis, but it has not been returned.Therefore, failure analysis of the product related to the complaint cannot be performed.Based on additional information obtained, the customer knowingly made the decision to continue using the damaged stapler sheath accessory.The endowrist stapler instruments and accessories user manual addendum provides the following warnings: caution: always close the jaws and straighten the wrist of the stapler before introducing or removing the instrument through the cannula.Caution: inspect the stapler sheath for damage during use.If damage is observed, remove and replace the sheath.Examples of damage include tears or cuts in the sheath material.Caution: do no use excessive force while inserting or removing instruments through the cannula because it may damage the seal and the sheath.If there is significant resistance, stop and check the seal and the sheath for damage.Replace the seal and/or sheath if damaged.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 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: 16925238
• Report Number: 2955842-2023-13157
• Device Sequence Number: 6920810
• Product Code: NAY
• UDI-Device Identifier: 00886874111130
• UDI-Public: (01)00886874111130(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: 410370-03
• Device Catalogue Number: 410370
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Hispanic
• Patient Race: White