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

Model Number 480460-09

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) will not receive the sureform 60 stapler instrument and sureform 60 white reload for evaluation per the customer response in follow-up questions.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is received.The instrument batch sequence number was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.In addition, a review of the site's complaint history identified no other complaints related to this event.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: the sureform 60 stapler instrument was unable to unclamp the instrument jaws.Although there was no report of patient injury, if this event were to recur it could cause or contribute to an adverse event.Device manufacture date: is blank because there was insufficient product information available to determine the manufacture date.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the customer encountered problems with the sureform 60 stapler instrument.The intuitive surgical, inc.(isi) clinical sales representative (csr) called in after the procedure to report that the customer contacted her to report the issue after they converted to laparoscopic surgery.The customer reported that there were issues with selecting the correct reloads, and the sureform 60 stapler instrument became stuck on tissue.The csr stated that the customer was able to remove the sureform 60 stapler instrument using the manual release knob (mrk), but then they elected to convert to laparoscopic surgery.The customer did not contact technical support to report the issue.The procedure was converted to laparoscopic surgery with no report of patient harm, injury or adverse outcome.Isi obtained the following additional information regarding the reported event: the procedure was converted to laparoscopic surgery because the sureform 60 stapler instrument would not fire, and the target tissue was in a position where it would be difficult to get the sureform 60 stapler instrument to where it needed to go.There was no system malfunction.The instrument was inspected prior to use and no issues were noted.The customer could not provide the lot number and batch sequence number of the sureform 60 stapler instrument.The surgeon was stapling the stomach with a white reload at the time of the event.The surgeon chose the white reload because it was his usual type of reload for this area in the surgery.The sureform 60 stapler instrument worked several times before it stopped, but it was not at its maximum firing usage.The sureform 60 stapler instrument was used for about 20 minutes.The scrub tech was not sure if it was the 3rd or 4th fire that was involved with the reported event.There were no errors when the issue occurred.The jaws of the sureform 60 stapler instrument just would not open.The surgeon did not encounter any obstructions between the jaws of the sureform 60 stapler instrument.There was no buttress material being used and it was unknown if there were any malformed staples.The surgeon was having difficulty placing the sureform 60 stapler instrument in the position where he wanted before clamping and firing.The target tissue was the stomach.The tissue was not calcified, nor exposed to radiation or chemotherapy.There was no tissue tension/bunching.There were no issues with using the manual release knob (mrk) to release the sureform 60 stapler instrument.There was no unexpected bleeding except for a slight bleeding on the staple line.There was no unexpected tissue removal.The customer confirmed there was no patient harm.The sureform 60 stapler instrument and white reload will not be returned for evaluation.There are no photographic images of the device(s) or a video recording of the procedure.The customer was not able to provide any patient-related information.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10898742
• MDR Text Key: 232193856
• Report Number: 2955842-2020-11258
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460-09
• Device Catalogue Number: 480460
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/24/2020
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1