MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST STAPLER 45; ENDOSCOPIC INSTRUMENT

Model Number 470298-11

Device Problem Device Issue (2379)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

The stapler 45 instrument has not been returned for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2017.No related system errors were found to have occurred during the surgical procedure.In addition, the system logs reveal that the stapler 45 instrument involved with the reported event has been used in subsequent da vinci-assisted surgical procedures.As of the date of this report, no subsequent complaints involving this particular stapler 45 instrument have been reported to isi.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the surgeon claimed that lung tissue tore while she was using the stapler 45 instrument and the patient experienced bleeding.In order to control the bleeding and complete the surgical procedure, the surgeon used a hand-held laparoscopic stapler instrument.However, at this time, the root causes of the customer reported failure mode and the patient's intra-operative complication are unknown.

Event Description

It was reported that during a da vinci-assisted pulmonary wedge resection procedure, lung parenchyma allegedly tore while the surgeon was using a stapler 45 instrument.The surgeon used a hand-held laparoscopic stapler instrument to control bleeding that ensued and in order to finish the surgical procedure.However, at this time, the root cause of the operative complication is unknown.On 12/05/2017, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the initial reporter indicated that she believes the surgeon was alleging that there was an issue with the smartclamp feedback feature of the stapler 45 instrument.The smartclamp feedback feature detects whether or not the stapler 45 instrument can adequately close on the target tissue during clamping.If while clamping the stapler 45 detects that the jaws cannot adequately close on the target tissue, clamping stops and the following message is displayed: inadequate clamp.Unclamp with blue pedal.According to the initial reporter, the surgeon claimed that the smartclamp feature allows her to clamp on tissue that is, at times too thick and ends up tearing.The surgeon also believes the issue with the smartclamp feedback feature sometimes leads to partial fires with the stapler 45 instrument.Although no blood transfusions were administered, the initial reporter did not know the estimated blood loss volume as a result of the alleged instrument issue.To the initial reporter's knowledge, no post-operative complications have been reported.She did not know the patient's current status.

• Brand Name: ENDOWRIST STAPLER 45
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7121628
• MDR Text Key: 94979626
• Report Number: 2955842-2017-00844
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470298-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention