MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD BLUE

Model Number 48360B

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intra-operative complication is unknown.Intuitive surgical, inc.(isi) has not received the sureform 60 stapler instrument and the blue reload involved with this complaint.Therefore, the root cause of the alleged customer reported failure mode cannot be determined.The stapler logs were reviewed by an isi advanced failure analysis engineer (fae) and the following findings were obtained: stapler with (part # 480460-09, lot # l90200322-0262) fired qty: seven (7) reloads (all blue) all firings were completed per the logs.Pauses for compression during firing ranged from 0 to 1.There were no incomplete clamps.A review of the video clip was conducted by an isi clinical development engineer (cde).The following additional information was provided: the video shows a sleeve gastrectomy procedure where the surgeon appears to staple across the stomach with blue reloads without issue.The staple formation and approximation of the staple line appears good.Some movement of the 34f tube inside the stomach (used during sleeve procedures to guide staple line placement) can be observed near the staple line as the surgeon inspects the staple line.Upon completing the staple line and inspecting it, the surgeon completes a leak test and is preparing to undock when some slow oozing of blood is observed at the proximal end of the staple line.The surgeon applies irrigation and suction to the oozing, but it persists to slowly bleed.The surgeon then decides to suture nearby omentum tissue to the proximal region of the staple line, which appears to stop the bleeding.Upon inspecting the distal end of the staple line, additional slow oozing is observed; therefore, the omentum is sutured to the distal end as well.The bleeding appears to be resolved at this point, and the procedure is completed.This complaint is being reported due to the following conclusion: during a da vinci-assisted sleeve gastrectomy procedure, there was oozing from the proximal and distal ends of the staple line made with a blue staple load using the sureform 60 stapler.The surgeon oversewed the affected areas along the staple line to control the ooze.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy procedure, there was alleged "oozing" from the proximal and distal ends of the staple line made with a blue staple load, using the sureform 60 stapler.The surgeon over sewed the bleeding staple line to ensure that bleeding was stopped.On (b)(6) 2020, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the surgeon had used a sureform 60 stapler instrument twice with blue loads with no issues.After the second (2nd) load, the physician¿s assistant (pa) pulled the instrument out to load and it got caught in the cannula as the instruments¿ wrist was not fully straightened.The pa ended up successfully removing the instrument without the use of a release kit.The same sureform 60 stapler instrument was loaded and reseated.Four more blue loads were fired, and all formed fine with no pause.As the surgeon made his way to the top (center part of the stomach), staple line slight ¿oozing¿ of blood was observed at the gastroesophageal junction (ge) junction and another area 2-3 cm below.The surgeon inspected the rest of the staple line further and noticed two more areas of slight oozing on the body part of the stomach and one at the bottom.The surgeon oversewed the affected areas along the staple line to control the minimal amount of oozing blood.The estimated blood loss was described as less than 10 cc¿s for the entire staple line; no blood transfusion was required.The surgeon believed the cause of the oozing could have been due to the patient`s thin stomach; there was nothing different with the patient¿s medications.The surgeon inspected the staple line at the end of procedure and everything ¿looked good, all formed, no bleeding.¿ the procedure completed robotically with use of the same sureform 60 stapler instrument.There have been no reports of post-operative complications.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60 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: 14861303
• MDR Text Key: 295124974
• Report Number: 2955842-2022-12572
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48360B
• Device Catalogue Number: 48360B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES