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

Model Number	48360G
Medical Device Problem Codes	Failure to Form Staple (2579); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) will not receive the sureform 60 green reload for evaluation per the isi clinical territory associate response in follow-up.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.A review of the instrument log showed the sureform 60 green reload (part #48360g) was used on (b)(6) 2021 during this reported procedure with a sureform 60 stapler instrument (part #480460-09 / lot #l90200519-0004) with system (b)(4).The sureform 60 green reload is single-use item.In addition, a review of the site's complaint history identified no other complaints related to the sureform stapler 60 green reload.An image of the sureform 60 green reload related to this event was received.A review of the submitted image was performed, and it was confirmed that one of the staples did not release from the sureform 60 green reload pocket.This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted duodenal polypectomy surgical procedure, the sureform 60 stapler instrument allegedly fired a sureform 60 green reload, but the staple line was not optimum.The surgeon switched to the sureform 60 blue and white reloads using the same sureform 60 stapler instrument and had no further issues with the staple line.It was confirmed that one of the staples was stuck and did not release from the sureform 60 green reload pocket.Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event.
Event or Problem Description
It was reported that during a da vinci-assisted duodenal polypectomy surgical procedure, the intuitive surgical, inc.(isi) clinical territory associate (cta) called in to report that the sureform 60 stapler instrument fired a sureform 60 green reload, but the staple line was not optimum.The cta stated that it was the second fire of the sureform 60 stapler instrument.The reported event occurred on the first stapler fire of stomach tissue.The cta also reported that the surgeon switched to the blue and white reloads using the same sureform 60 stapler instrument and had no further issues with the staple line.The sureform 60 stapler instrument was disposed of prior to contacting technical support.The cta has an image of the sureform 60 green reload.The isi technical support engineer (tse) reviewed the onsite logs and found no faults related to the reported event.The procedure was completed with no reported injury.Isi obtained the following additional information regarding the reported event: the cta was present during the surgical procedure.The sureform 60 stapler instrument and the sureform 60 green reload were reportedly inspected prior to use, and no issues were noted.The cta noted that a scrub technician was changing out the sureform 60 green reload and noticed some staples were stuck in the sureform 60 green reload.The surgeon chose the sureform 60 green reload because his reload algorithm for stapling the stomach is 1 - 2 sureform 60 green reloads (depending on tissue thickness), then uses sureform 60 blue reloads the rest of the way until he reaches the fundus.As for this case, he used one sureform 60 green reload for the 1st staple fire, and then he used the sureform 60 blue reloads for the remainder of the case.There were no errors/messages at the time of the event.The stapler fire was completed successfully.Prior to firing the sureform 60 stapler instrument, the surgeon did not experience any clamping issues, nor any obstructions between the jaws of the sureform 60 stapler instrument.There was no buttress material used.There were no malformed staples.The tissue was not calcified.There was no tissue tension/bunching.It was confirmed there was no patient harm, injury or adverse outcome.The sureform 60 stapler instrument and sureform 60 green reload are not available for return to isi for evaluation.The cta does not know if there is a video recording of the procedure.No patient-related information was available.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD GREEN
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11389465
• Report Number: 2955842-2021-10178
• Device Sequence Number: 18495259
• Product Code: GDW
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: 48360G
• Device Catalogue Number: 48360G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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