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

Model Number	48345B-01
Medical Device Problem Codes	Material Fragmentation (1261); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, a "missing or used reload" message was displayed with a new reload.The customer reseated the sterile adapter and reload but the reload was not recognized.The customer attached a different reload and it was recognized.The rest of the reloads were able to be used with no problem at all.The customer noted a staple fell inside the patient's body immediately after the reload was installed.The customer was able to retrieve the staple.The reload could not be used after.A backup reload was installed to continue.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with a doctor and obtained the following additional information: only one staple fell inside the patient.An assistant was able to retrieve the staple from the patient.There was no post-operative tests performed to check for remaining fragments.The issue occurred during the third firing.The product was inspected prior to use and no abnormality was found.The staple fell inside the patient when the stapler and reload was being removed.There was no issue with the functionality of the instrument prior to the issue.The instrument did not collide with any other instruments or other hard material during the surgical procedure.The patient sustained no injury and has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.No video recording of the procedure was available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not yet received the blue sureform 45 reload.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 received for testing 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 and/or this event.No image or video clip for the reported event was available for review.A review of the stapler logs for the sureform 45 stapler (pn 480545-04, lot t91211122-0206) associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The logs show quantity of two sureform 45 curved tip instruments were used in this procedure, but only one instrument used blue reloads, and that is pn 480545-04, lot t91211122-0095.This instrument had a total of nine installs with blue reloads, and seven installs resulted in firings of the blue reloads.All seven blue firings were completed per the logs with no pauses for compression.Logs will not be able to determine which specific blue reload the complaint occurred with.A review of the procedure logs showed this pulmonary lobectomy surgical procedure was used on 08-june-2022 with system sl0836.Per this review of the logs, the stapler sureform 45 curved tip (part# 480545-04 | lot/serial# t91211122-0095) was last used on (b)(6) 2022 via system serial# (b)(4).There were 12 uses used during this procedure and 0 use remaining after this last usage.In addition, stapler sureform 45 curved tip (part# 480545-04 | lot/serial# t91211122-0093) was last used (b)(6) 2022 via system serial# (b)(4).There were 11 uses remaining after this last usage.A total of 13 reloads were used - 7 blues, 3 white, and 3 green.This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument broke and a fragment fell inside the patient during a da vinci assisted procedure.The fragment was retrieved during the same procedure with no patient injury.At this time it is unknown what caused the breakage to occur.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the blue sureform 45 reload involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.Failure analysis found the primary finding of cannot verify external event to be related to the customer reported complaint.Upon visual inspection, the returned reload appeared to be unused and unfired.The reload was installed in an in-house sureform 45 instrument and tested on the in-house system.The reload was recognized and fired without any issues.No errors occurred and no damages were found.The accessory was fully functional.There was no problem detected.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 14961228
• Report Number: 2955842-2022-12850
• Device Sequence Number: 6944478
• 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,Followup
• Report Date (Section B): 06/08/2022

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 0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 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 Sex: Unknown