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

Model Number	48345B-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.The sureform 45 blue reload used during this event has not yet been received for further evaluation, but was requested for return.A follow-up mdr will be submitted if additional information is obtained.A review of the system logs for the procedure date of (b)(6) 2021 has been performed and the following was observed: no relevant errors were observed during this procedure.Additionally, the sureform 45 stapler instrument used during this procedure is a single use instrument and therefore was not used in subsequent procedures.Eight sureform 45 blue reloads and one sureform 45 white reload were fired with this instrument.An isi senior failure analysis engineer reviewed the stapler logs for the stapler used in this event and the following info was provided: ¿logs show that pn 480445-04, lot l90210701-0187 was installed 10 times and fired qty 9 reloads (1 white followed by 8 blue).All firings were completed per the logs with no pauses for compression.There was 1 incomplete clamp on the first install using the white reload.¿ no images or videos were obtained for this reported event.This event is being reported due to the following conclusion: after undergoing a da vinci-assisted sigmoid colectomy procedure, the patient reportedly returned to the hospital with a staple line leak.The sureform 45 blue reload fired during this event potentially did not deliver all staples as expected causing/contributing to this event.At this time, the cause of the post-operative complication is unknown.
Event or Problem Description
It was reported that after a da vinci-assisted sigmoid colectomy that the patient returned to the hospital (two days post-operative) with abdominal pain.The customer reported that "a pin size hole" was discovered in one of the staple lines.The surgeon was reportedly questioning this staple line and believed it may have contributed to the event.The patient underwent an exploratory laparotomy to close the hole.On 16-nov-2021, intuitive surgical inc.(isi) contacted the surgeon of this procedure and additional information was obtained about the complaint: the patient had a large polyp on the cecum.This procedure was a right colectomy with intracorporeal anastomosis.The staple line that leaked was where an isoperistaltic side to side anastomosis was done with a blue stapler reload.Firefly mode was used to assess vasculature and reportedly worked well.The patient did well post-operatively for about 48 hours, but developed acute abdominal pain and returned to the hospital.A physical exam was performed and the site became suspicious of an anastomotic leak.The patient was taken to the operating room (or) for an exploratory operation.During the surgery, a 2mm leak was noticed at the apex of the small bowl and transverse colon anastomosis.This area was resected to resolve the issue.The colon was closed and an end ileostomy was created.The surgeon reported that they believe this leak occurred due to an error of the sureform 45 stapler instrument and sureform 45 blue reload because of the short amount of time between the procedure and the patient¿s return to the hospital.The surgeon reported that the instrument was discarded.The patient is reportedly doing well.The surgeon reported that the pathology report showed no cancer and they plan to re-operate on this patient in three to four months for restoration of intestinal continuity.

• 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: 12858430
• Report Number: 2955842-2021-11574
• Device Sequence Number: 17209828
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• 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
• Report Date (Section B): 10/26/2021

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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 88 KG