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	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the endowrist stapler sheath fell inside of the patient.The item was successfully retrieved and the procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer noted a tear almost completely circumferentially.The piece was retrieved with a da vinci cadiere grasper.It was confirmed that all fragments were retrieved; the customer pieced together the completely torn sheath and compared it to a whole sheath.No additional surgical procedure was needed.There were no post-operative tests performed.The surgeon is not aware of what could have contributed to the tear.The accessory was inspected prior to use and no defects were noted.The issue was noted during the instrument removal.There was no issue with the functionality of the instrument.The instrument did not collide with any other instrument or other hard material during the surgical procedure.The instrument was removed prior to the accessory tear and the wrist was straightened at that time with no resistance through the cannula reported.Upon final removal, the wrist was also straightened, with no resistance and no damage on the cannula.The patient has not returned to the hospital with post-surgical complications due to the failure.The accessory is available for return to isi for failure investigation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the disposable stapler sheath 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 product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.A log review of the product related to the complaint cannot be performed because the product is an accessory and does not appear in system logs.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the stapler sheath fell inside of the patient.The fragment was retrieved during the same procedure.At this time it is unknown what caused the stapler sheath to tear and fall inside the patient.Blank mdr field information: follow-up was attempted, but the patient information for blank fields was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the disposable stapler sheath accessories involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.A visual inspection found the part to be damaged.The sheath was torn in multiple locations.The root cause is not determinable/applicable.Additional observation(s) related to customer reported complaint: the sheath was torn in multiple locations, therefore, the part cannot be tested due to damage.The root cause attributed to damage part is not determinable/applicable.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 13555497
• Report Number: 2955842-2022-10272
• Device Sequence Number: 17098400
• Product Code: NAY
• UDI-Device Identifier: 00886874111130
• UDI-Public: (01)00886874111130(10)M90210812
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 410370-03
• Device Catalogue Number: 410370
• Device Lot Number: M90210812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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: Unknown
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White