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

Model Number 48360B

Device Problem Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the sureform 60 stapler instrument (pn: 480460-08 || ln: l91200115 0188) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed nor replicated.The stapler instrument was tested in-house and it initialized, clamped, fired, and unclamped without any issues.The instrument moved intuitively with full range of motion in all directions and the grips opened and closed properly.Upon visual inspection, there was no physical damage found.A review of logs showed no failures.The instrument was fully functional and no problem was detected.If additional information is received, a follow-up mdr will be submitted.In addition, 8 sureform 60 blue reloads involved with this complaint were received and evaluated.1 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.There were no undeployed pushers or cartridge damage observed.Root cause is no problem detected.A review of logs found no firing failures.Additional observation(s) not reported by site: the reload was disassembled in-house for inspection and the knife was found to exhibit blade damage.Root cause is not attributed to the product.2 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.The reload was disassembled in-house for inspection and no damages were found.No undeployed pushers were observed.A review the logs showed no firing failures.Root cause is no problem detected.3 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.There were no undeployed pushers or cartridge damage observed.Root cause is no problem detected.A review of logs found no firing failures.Additional observation(s) not reported by site: the reload was disassembled in-house for inspection and the knife was found to exhibit blade damage.Root cause is not attributed to the product.4 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.The reload was disassembled in-house for inspection and no damages were found.No undeployed pushers were observed.A review the logs showed no firing failures.Root cause is no problem detected.5 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.There were no undeployed pushers or cartridge damage observed.Root cause is no problem detected.A review of logs found no firing failures.Additional observation(s) not reported by site: the reload was disassembled in-house for inspection and the knife was found to exhibit blade damage.Root cause is not attributed to the product.6 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.There were no undeployed pushers or cartridge damage observed.Root cause is no problem detected.A review of logs found no firing failures.Additional observation(s) not reported by site: the reload was disassembled in-house for inspection and the knife was found to exhibit blade damage.Root cause is not attributed to the product.7 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.There were no undeployed pushers or cartridge damage observed.Root cause is no problem detected.A review of logs found no firing failures.Additional observation(s) not reported by site: the reload was disassembled in-house for inspection and the knife was found to exhibit blade damage.Root cause is not attributed to the product.8 of 8 returned reloads: intuitive surgical, inc.(isi) received the sureform 60 blue reload (pn: 48360b-08) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed.Upon visual inspection, the reload appeared to be used and fired without any issues.There were no undeployed pushers or cartridge damage observed.Root cause is no problem detected.A review of logs found no firing failures.Additional observation(s) not reported by site: the reload was disassembled in-house for inspection and the knife was found to exhibit blade damage.Root cause is not attributed to the product.No image or video clip for the reported event was submitted for review.System error log review was conducted during the support call and no related errors were identified.System error log review was also conducted on (b)(6) 2021 for a procedure on (b)(6) 2021 on system (b)(4).While there were various entries related to the camera, scope and trumpf table, there were no observed events in the system logs that would suggest a related errors and logged events are in line with normal system functionality.A review of the instrument logs was also performed.Single use sureform 60 stapler pn: 480460-08 || ln: l91200115-0188 || sn: (b)(4) was recorded in use and there were eleven logged entries for sureform 60 blue reloads pn: 48360b and one logged entry for a sureform 60 white reload pn: 48360w.While not all other reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against those instruments, including the reusable instruments that were used in subsequent procedures through their end of uses.An isi advanced failure analyst (afa) engineer conducted a stapler log review and found the following: stapler instrument pn 480460-08 || ln: l91200115-0188 fired twelve reloads (11 blue, 1 white).The white reload was the 6th firing.All firings were completed per the logs with no pauses for compression during any of the firings.There were no incomplete clamps in the procedure.While there was a report of the surgeon applying a, ¿smaller gastric pouch than originally planned¿, additional follow-up confirmed the following: while measurements were not taken for this case, an average pouch is normally 30-35cc, this pouch was approximately 27-30ccs.The surgeon ¿took the staple line in another, roughly, 3-5mm to re-approximate¿.Transecting 3-5mm of additional stomach tissue is considered trivial.The tissue removal would not be considered an adverse event as it did not cause permanent impairment.However, this complaint is considered a reportable malfunction due to the following: the procedure completed robotically, yet it was alleged that staples were missing from the staple line with unknown cause.If not recognized during the procedure, medical intervention, including additional surgical procedures, may be required in the event that the staples are not delivered from the reload.At this time, it is unknown what caused the event to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

During a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, as the surgeon was stapling the gastric pouch with a sureform 60 stapler instrument in arm 4 and blue reloads, there was an incomplete staple fire with a blue reload.The surgeon said that it looked like the sledge wedge completed the full 60mm length, but only partial staples were noticed on the left side of the staple line.No malformed staples nor leakage was observed.It was noted the instrument had completed 3 firings prior to the stapler issue on the 4th fire.To resolve the issue, the surgeon fired a 5th blue reload, with the same sureform 60 stapler instrument, over the previous partially laid staple line and slightly medially created a smaller gastric pouch than originally planned.Per follow-up with the surgeon, it was noted that the average pouch is normally 30-35cc, this pouch was approximately 27-30ccs and was taken in an extra roughly, 3-5mm to re-approximate.According to the surgeon, transecting 3-5mm of additional stomach tissue is considered trivial, and ¿not a big deal.¿ the procedure completed robotically with no reported patient harm or injury.There have been no reports of post-operative complications.There were no system generated error messages.The patient tissue was normal and no bunching was observed during the stapler clamping sequence.The surgeon did not encounter any obstructions between the instrument jaws.No image was available for review.The sureform 60 stapler instrument was inspected prior to use, and stated the instrument jaws were rinsed out prior to the 4th firing.All blue reloads are expected to be returned to isi for evaluation.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11640164
• MDR Text Key: 268209793
• Report Number: 2955842-2021-10380
• Device Sequence Number: 1
• Product Code: NAY
• 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: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1