MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST ONE VESSEL SEALER; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 410322-05

Device Problem Failure to Deliver Energy (1211)

Patient Problems Discomfort (2330); Blood Loss (2597)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

The endowrist one vessel sealer instrument will not be returned to isi for failure analysis evaluation as the instrument was discarded by the customer.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.Review of the site's system logs for the reported procedure date found that no system errors were generated that would have caused or contributed to the post-operative bleeding experienced by the patient.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event.Based on the information provided, this complaint is being reported due to the following conclusion: it was alleged that post a da vinci-assisted surgical procedure, the patient experienced post-operative bleeding, requiring the patient to undergo a secondary surgical procedure to resolve the bleeding issue.It is unknown what caused the post-operative bleeding experienced by the patient.

Event Description

It was reported that after completion of a da vinci-assisted surgical procedure, the patient returned to the hospital due to post-operative bleeding.The intuitive surgical, inc.(isi) clinical sales representative (csr) reported that the patient had a da vinci-assisted procedure on (b)(6) 2017 and days later returned to the hospital due to bleeding.The surgeon then recalled that during the procedure, the endowrist one vessel sealer instrument was responding slowly but that no complications were observed during the procedure.The surgeon did not report any slow movement or slow responses from the endowrist one vessel sealer instrument.Furthermore, the error logs did not capture any errors from the endowrist one vessel sealer instrument.On 12/04/2017, isi followed up with the isi csr and obtained the following additional information: the patient had undergone a da vinci-assisted sleeve gastrectomy procedure and on post-operative day 2, the patient returned to the hospital due to a feeling of discomfort.The patient then underwent an unspecified secondary surgical procedure and it was found that the patient was bleeding from the short gastric vessels.The surgeon was able to resolve the bleeding experienced by the patient.The surgeon then informed the isi csr that during the da vinci-assisted surgical procedure, the endowrist one vessel sealer instrument was used to seal the patient's short gastric vessels and during a couple of sealing cycles, it was noted that the sealing took longer.The surgeon stated that both the sealing cycle tones and the end of the sealing cycle tones were heard.The surgeon indicated that there was no malfunction of the da vinci surgical system during the procedure.The surgeon does not know what caused the post-operative bleeding experienced by the patient.The csr was not able to confirm if the patient required a blood transfusion.The csr did indicate that the patient was recovering well.It was confirmed that the endowrist one vessel sealer instrument was discarded.A field investigation was performed by an isi field service engineer (fse).The fse inspection the site's da vinci surgical system and the erbe generator.The fse installed an emulator instrument and performed cut testing and sealing motions with no issues found.The fse verified that the system functioned within isi specifications.

• Brand Name: ENDOWRIST ONE VESSEL SEALER
• Type of Device: ENDOSCOPIC ELECTROSURGICAL 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: 7085376
• MDR Text Key: 93807877
• Report Number: 2955842-2017-00814
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110639
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322-05
• Device Lot Number: M10170609 271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention