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

Model Number	48230B-02
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the intra-operative complication cannot be determined.Intuitive surgical inc.(isi) requested for return of the blue reload used during this event, but the product has not been received.A follow-up mdr will be submitted if additional information is obtained.A system log review was performed for this procedure: no relevant errors were observed during this procedure.An isi failure analysis engineer reviewed the stapler logs for this procedure: the logs show that 8mm curved-tip sureform 30 stapler instrument (part #488530-10, lot #u90220315-0021) was installed 8 times and fired 8 reloads (3 blue - 4 white - 1 blue, in that order).All firings were completed per the logs with no pauses for compression.There were no incomplete clamps by this instrument.This event is being reported due to the following conclusion: during a da vinci-assisted pulmonary tri-segmentectomy procedure, a staple line bleed was observed after an 8mm curved-tip sureform 30 stapler instrument was used to fire a blue reload on parenchyma.The surgeon used bipolar energy to stop the bleeding.The cause of the intra-operative complication is unknown.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary left upper tri-segmentectomy procedure, an 8mm curved-tip sureform 30 stapler instrument was used to fire a blue reload on parenchyma.The staple line reportedly oozed blood and as a result, the surgeon applied energy via a long bipolar grasper instrument to cauterize and stop the bleeding.The surgeon performed an air leak at the end of the case and no leaks were observed.The procedure was completed robotically.The surgeon said the patient was discharged from the hospital.

• 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: 14888313
• Report Number: 2955842-2022-12719
• Device Sequence Number: 20124628
• Product Code: NAY
• UDI-Device Identifier: 10886874121914
• UDI-Public: (01)10886874121914(10)U90220330
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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: 48230B-02
• Device Catalogue Number: 48230B
• Device Lot Number: U90220330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male