MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD GREEN

Model Number 48630G-02

Device Problem Device Issue (2379)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

The green stapler 30 reload involved with the reported event has not been returned to intuitive surgical, inc.(isi); therefore, the root cause of the customer reported failure mode is unknown.The date the da vinci-assisted surgical procedure was performed is unknown.Therefore, the system logs cannot be reviewed at this time.Based on the current information provided, this complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the stapling of the parenchyma was allegedly incomplete and the patient experienced ¿persistence of parenchymal bleeding.¿ however, at this time the root causes of the customer reported failure mode and the patient¿s intra-operative complications are unknown.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the surgical staff noticed that the ¿stapling of the parenchyma was not complete.¿ as a result of the alleged issue, the patient experienced ¿persistence of parenchymal bleeding.¿ in order to overcome the problem, the surgical staff replaced the ¿refill.¿ according to the initial reporter, ¿no clinical consequences are to be deplored.¿ no other information was provided.The following information is unknown: what date the surgical procedure was performed, the blood loss volume, and what medical intervention, if any, was administered due to the intra-operative complications.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received a green stapler 45 reload that was reportedly involved with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint that "stapling of the parenchyma was not complete." the reload was found to have a damaged blade.The known common cause of this failure is mishandling/misuse.In addition, the reload appeared to be only fired half way.Based on the current information provided, this complaint will remain reportable due to the following conclusion: during the da vinci-assisted surgical procedure, the stapling of the parenchyma was allegedly incomplete and the patient experienced ¿persistence of parenchymal bleeding.¿ however, at this time the root cause of the patient¿s intra-operative complications is still unknown.In addition, there is no evidence that a malfunction of the green stapler 45 reload occurred.The blade damage found during the evaluation of the reload can be attributed to mishandling/misuse.

Manufacturer Narrative

The event date has been updated to "(b)(6) 2018.".

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 30 RELOAD GREEN
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 7372099
• MDR Text Key: 103518176
• Report Number: 2955842-2018-10104
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K152421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48630G-02
• Device Lot Number: M11171103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention