MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLUE

Model Number	48345B-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sureform 45 blue reload will not be returned for evaluation as it has been discarded by the customer.Therefore, failure analysis of the product related to the complaint cannot be performed and the root cause of the customer reported failure mode has not been determined.A follow up mdr will be submitted if additional information is received.Event verification: a review of the device logs for the sureform 45 curved-tip stapler (part# 480545-04 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the sureform 45 curved-tip was last used on (b)(6) 2022 via system serial# (b)(4) for a pneumonectomy lobectomy surgical procedure, there were 5 uses remaining after this last usage.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.Stapler log review: a review of the stapler logs for the sureform 45 curved-tip stapler (pn 480545-04, lot t91211122-0206) associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).Logs show that the stapler was installed 7x and fired 7 reloads (2 gray -> 1 white -> 2 blue -> 1 green -> 1 blue, in that order).All firings were completed per the logs.Firing #2 had one pause for compression, and all others had no pauses.There were no incomplete clamps by this instrument.Video review: isi received a video clip related to the alleged complaint.A review of the video clip was conducted by clinical development engineer (cde).The following additional information was provided: the cde confirmed the presence of an unformed staple on the tissue beneath the stapler after the surgeon brushed tissue along the anvil.It is possible that the unformed staple was left in the jaws of the stapler from a previous fire, but this cannot be confirmed from the video alone.Unformed staples rarely fall out of reloads.The user manual (pn 555070-03) instructs the user to make sure the jaws are clear of debris, including loose staples, before installing a new reload and firing.This complaint is being reported due to the following conclusion: during a da vinci-assisted pneumonectomy lobectomy surgical procedure, it was alleged that a staple fell inside the patient.The staple was retrieved during the same procedure with no patient injury.
Event or Problem Description
It was reported that during a da vinci-assisted pneumonectomy lobectomy surgical procedure, after cutting between the leaves, a u-shape staple from the sureform 45 reload fell near the cutting line before b-shape formation.The customer immediately retrieved the staple from the patient.The customer was using multiple blue reloads and couldn't identify when it fell.The customer used a backup reload to continue.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following additional information: the staple fell on the patient's lung.The surgeon grasped the staple and removed it from the patient.All staples were retrieved and confirmed.No post-operative tests like x-ray or ultrasound were performed to check for remaining fragments.The instrument was visually inspected prior to use and no damage was found.The staple was found after the completion of a fire.It was unknown if the instrument collided with any other instruments or other hard material during the surgical procedure.The instrument was removed during the procedure multiple times prior to the breakage.No bleeding occurred.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The reload has been discarded and will not be returned.No photographic images were available for review.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLUE
• 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: 14198013
• Report Number: 2955842-2022-11253
• Device Sequence Number: 14561787
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)L90211025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2022

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: 48345B-01
• Device Catalogue Number: 48345B
• Device Lot Number: L90211025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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: 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