SUREFORM
Report
- Report Number
- 2955842-2024-18463
- Event Type
- Injury
- Date Received
- August 22, 2024
- Date of Event
- July 3, 2024
- Report Date
- July 26, 2024
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- GDW
- PMA / PMN Number
- K183224
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- 003
Narratives
BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT OR STAPLER 45 RELOAD THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. THE STAPLER LOGS SHOW A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT (PART #480545-04; LOT #T11230905-0212) WAS INSTALLED ON THE SYSTEM 9 TIMES AND FIRED 8 RELOADS (1 GREEN, 1 WHITE, 2 GREEN, 3 BLACK, 1 GREEN, IN THAT ORDER). ON INSTALLS 1-8, THE FIRST CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 9, A BLACK RELOAD WAS LOADED, HOWEVER NO CLAMPING OR FIRING WAS ATTEMPTED. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO RELEVANT STAPLER ERRORS IN THE LOGS.
INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY PROCEDURE INVOLVED THE LEFT UPPER LOBE. THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WAS INSPECTED AND THERE WERE NO CLAMPING ISSUES PRIOR TO USE. THE STAPLER INSTRUMENT WAS FIRED WITH A GREEN SUREFORM 45 RELOAD DUE TO THE THICKNESS OF THE PARENCHYMA BUT FAILED TO FULLY ENGAGE THE STAPLES AND DID NOT CUT THROUGH THE LUNG TISSUE. THE STAPLES WERE DESCRIBED AS PARTIALLY OPENED AND THERE WERE UNFORMED STAPLES. THERE WERE ALSO MISSING STAPLES FROM THE STAPLE LINE. AS A RESULT, THE STAPLE LINE HAD HOLES/GAPS. WHEN THE STAPLER INSTRUMENT WAS UNCLAMPED, THE LUNG PARENCHYMA TISSUE TORE AND CAUSED BLEEDING. THE AMOUNT OF BLEEDING WAS NEGLIGIBLE AS THE TARGET TISSUE WAS LUNG PARENCHYMA, WITHOUT BIG VESSELS. THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. THE SURGEON DOES NOT REMEMBER IF ANY ERROR MESSAGES WERE OBSERVED, BUT BELIEVED THE EVENT OCCURRED ON THE 8TH STAPLE FIRE. AFTER THE EVENT, THE STAPLER INSTRUMENT WOULD NOT ACCEPT ANOTHER STAPLER RELOAD AND WAS REMOVED USING THE STAPLER RELEASE KIT (SRK) AND A BACKUP STAPLER INSTRUMENT WAS THEN USED. A SMALL AMOUNT OF THE PULMONARY PARENCHYMA WAS EXCISED WITH THE BROKE STAPLE LINE TO AVOID A POST-OPERATIVE AIR LEAK. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THERE WERE NO POST-OPERATIVE COMPLICATIONS; THE PATIENT IS FEELING WELL.
ADDITIONAL INFORMATION: THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WAS EVALUATED BY ADVANCE FAILURE ANALYSIS (AFA) AND FURTHER REVIEW FOUND THE I-BEAM WAS DRIVEN OUT FOR INSPECTION. UPON EXTENSION, IT WAS NOTED THAT THE I-BEAM SHOE ON THE CHANNEL SIDE HAD BROKEN OFF. BOTH THE ANVIL AND CHANNEL SIDE SHOES OF THE I-BEAM RIDE ALONG A GROOVE THAT CLOSES THE JAWS AS THE I-BEAM ASSEMBLY IS DRIVEN FORWARD. DUE TO THE BREAK OF THE SHOE, THE JAWS REMAINED OPEN THROUGH FULL EXTENSION AND RETRACTION. THERE ARE MISSING FRAGMENTS OF THE I-BEAM CHANNEL SIDE SHOW THAT WEREN'T RECEIVED WITH THE INSTRUMENT, NOR IDENTIFIED VIA FA. HOWEVER, THE POTENTIAL FOR FRAGMENTS FALLING INTO THE PATIENT ARE LOW, AS THE BREAK IS LOCATED ON THE CHANNEL SIDE OF THE JAWS, AND ANY FRAGMENTS WOULD BE CONTAINED BY THE RELOAD DURING FIRING, AND UNTIL REMOVAL WHILE OUTSIDE OF THE PATIENT. THE BREAK SURFACE OF THE REMAINING COMPONENT WAS NOTED TO BE GRANULAR AND ROUGH, WHICH IS AN INDICATION OF POTENTIAL HYDROGEN EMBRITTLEMENT. COMPONENT HISTORY CONFIRMS THIS I-BEAM WAS MANUFACTURED BY LISI, PRIOR TO THE IMPLEMENTATION OF A POST-BAKE OF THE MATERIAL AS PART OF THE MANUFACTURING PROCESS. EVIDENCE SUGGESTS THAT THE I-BEAM BREAK WAS LIKELY CAUSED BY HYDROGEN EMBRITTLEMENT, WHICH CAN OCCUR DURING PROCESSING, WEAKENING THE INTERNAL INTEGRITY OF THE METAL. A PROCESS STEP HAS SINCE BEEN IMPLEMENTED IN MANUFACTURING AS THE RESULT OF PREVIOUS I-BEAM BREAKS DUE TO HYDROGEN EMBRITTLEMENT. THE PROCEDURE LOGS DO NOT SHOW A FIRING FAILURE, AS THE I-BEAM WAS ABLE TO TRAVEL THE WHOLE LENGTH OF THE RELOAD WITHOUT DETECTING A FIRING FORCE THAT WOULD EXCEED THE PRE-DETERMINED FIRING FORCE THRESHOLD. THE SUREFORM 45 GREEN RELOAD ACCESSORY (1) WAS EVALUATED BY AFA AND WHICH CONFIRMED THE INITIAL FA FINDINGS AND UPON FURTHER REVIEW, THE RELOAD WAS FOUND WITH SKIVING BEGINNING AT THE PROXIMAL END OF THE KNIFE TRACK. THE SKIVING BEGAN PRIOR TO THE KNIFE INTERACTING WITH ANY TISSUE, INDICATING THE I-BEAM HAD LIKELY BROKEN PRIOR TO THE FIRING. THE SKIVING OF THE CARTRIDGE MATERIAL CONTINUED TO THE DISTAL END. THE SKIVING OF THE RELOAD KNIFE TRACK IS ATTRIBUTED TO THE BROKEN I-BEAM OF THE STAPLER, WHICH HAS A SUPPLIER MANUFACTURING ROOT CAUSE. THE DAMAGE TO THE RELOAD IS CONSIDERED AN EFFECT OF THE BROKEN I-BEAM. THE BLADE WAS FOUND WITH MECHANICAL INDENTATIONS TO THE TOP HALF OF THE CUTTING EDGE. THE SUREFORM 45 GREEN RELOAD ACCESSORY (2) WAS EVALUATED BY AFA AND CONFIRMED THERE IS NO DAMAGE TO THE RELOAD COMPONENTS. THIS INVESTIGATION IS UNABLE TO VERIFY THE REPORTED EVENT OCCURRED WITH THIS RELOAD, AS THERE ARE NO FAILURES IN THE LOGS, AND NO DAMAGE WAS FOUND ON THE RELOAD.
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA) AND DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE CHANNEL SPRANG BACK OPEN WHEN IN THE UNCLAMPED STATE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS NOT ABLE TO COMPLETE A FIRING TEST DUE TO THE JAWS NOT FULLY CLOSING. THE INSTRUMENT WAS FOUND TO HAVE A LOOSE SNAKE WRIST CABLE AT THE PROXIMAL END. AS A RESULT, THE INSTRUMENT JAWS WERE UNABLE TO CLOSE FULLY. THERE WAS NO DAMAGE FOUND TO THE SNAKE WRIST CABLE OR THE CLAMPING PULLEY. THE INSTRUMENT DID NOT FAIL ENGAGEMENT. ADVANCE FA CLARIFIED THAT THE INSTRUMENT DID NOT HAVE A BINDING ROLL BUSHING; AND THAT THE INCREASED FRICTION DURING MANUAL ROTATION OF THE MAIN TUBE IS MORE LIKELY RELATED TO THE CORROSION OF THE ROLL BEARING THAT WAS OBSERVED. CORROSION CAN DEVELOP DURING TRANSIT AND/OR STORAGE AND WAS LIKELY NOT PRESENT DURING THE PROCEDURE. ISI DID RECEIVE A SUREFORM 45 GREEN RELOAD ACCESSORY (1) TO PERFORM FA AND DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE GREEN RELOAD WAS RETURNED USED AND FIRED. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE TO THE KNIFE, PUSHERS, OR COVER. NO PRODUCT ISSUE WAS IDENTIFIED. ADDITIONAL FA FINDINGS, NOT REPORTED BY THE CUSTOMER: CARTRIDGE DAMAGE WAS OBSERVED IN THE KNIFE TRACK. A PIECE OF THE CARTRIDGE WAS FOUND WEDGED IN BETWEEN THE KNIFE TRACK. THERE WAS DAMAGE FOUND WITHIN THE KNIFE TRACK ON BOTH THE DISTAL AND PROXIMAL END. THE KNIFE WAS INSPECTED AND THERE WAS NO DAMAGE FOUND. ISI DID RECEIVE A SUREFORM 45 GREEN RELOAD ACCESSORY (2) TO PERFORM FA AND DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE GREEN RELOAD WAS RETURNED USED AND FIRED. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE TO THE KNIFE, PUSHERS, CARTRIDGE, OR COVER. NO PRODUCT ISSUE WAS IDENTIFIED.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING WHEN LUNG PARENCHYMA TISSUE TORE. THE EVENT OCCURRED WHEN THE SURGEON UNCLAMPED THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT. THE STAPLER INSTRUMENT HAD INITIALLY FIRED, BUT FAILED TO FULLY ENGAGE THE STAPLES AND DID NOT CUT THROUGH THE LUNG TISSUE. THE AMOUNT OF BLEEDING IS UNKNOWN BUT WAS RESOLVED WITHOUT CONVERTING TO OPEN SURGERY. AFTER THE EVENT, THE STAPLER INSTRUMENT WOULD NOT ACCEPT ANOTHER STAPLER RELOAD AND A BACKUP STAPLER INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE PATIENT IS FEELING WELL. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1741872 | SUREFORM | SUREFORM 45 RELOAD | GDW | INTUITIVE SURGICAL, INC | 48345 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | Required Intervention | DA VINCI INSTRUMENTS AND ACCESSORIES |