MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	48230M-02
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the reload, stapler 30 involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint of "tip is flimsy and bends when installing".For clarification, the stapler 30 reload was broken at the proximal end.There was no material to be noted that appeared to be missing.The reload has not been fired at all.Failure analysis determined that the root cause is attributed to the user.Verification of the event details via system logs cannot be performed at this time because there is insufficient event date information.No image or video clip for the reported event was submitted to isi for review.This complaint is considered a reportable event due to the following conclusion: failure analysis (fa) identified that a component of the reload stapler experienced a break, and while the break did not result in fragments falling into the patient, it was determined that this reported failure mode presents a potential hazard for fragments falling that could likely cause or contribute to an adverse event if it were to recur, as unintended broken fragment(s) falling inside the patient may require surgical intervention.If additional information becomes available a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the reload, stapler 30 tip was flimsy and bent when installing.The procedure was completed robotically with no patient injury reported.Follow-up was attempted to request additional information related to the event.However, no further details have been received as of the date of this report.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 15741030
• Report Number: 2955842-2022-15100
• Device Sequence Number: 14182563
• Product Code: GDW
• UDI-Device Identifier: 10886874121938
• UDI-Public: (01)10886874121938(10)U90220518
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48230M-02
• Device Catalogue Number: 48230M
• Device Lot Number: U90220518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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: ISIFA2022-10-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White