MAUDE Adverse Event Report: US SURGICAL PUERTO RICO SURGIWAND II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number 178091

Device Problems Mechanical Problem (1384); Melted (1385); Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy, when cautery was activated to separate the gall bladder from the liver, burning mark on surrounding tissue due to the melting sheath and the hook could not be hidden completely were noted.Another device from the other company was used to resolve the issue.

Manufacturer Narrative

Additional information: d9, g3, h3, h6.Correction: manufacturer information.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the sleeve of the instrument was damaged.It was reported that the device showed signs of melting, there was a device related burn, and the l-hook was exposed.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The issue can occur if the sleeve of the device is not fully retracted during use or the tip of the device contacts conductive irrigation fluid or other conductive material such as metal.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: when using electrocautery, ensure that the outer sleeve is fully retracted to expose the tip of the device, as failure to do so may compromise discharge of energy from the electrode.When using electrocautery, ensure that the electrode is not in contact with cond uctive irrigation fluid, as this may compromise discharge of energy from the electrode.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIWAND II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 11642001
• MDR Text Key: 244662537
• Report Number: 2647580-2021-01251
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884523000894
• UDI-Public: 10884523000894
• Combination Product (y/n): N
• PMA/PMN Number: K961771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

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
• Device Operator: Health Professional
• Device Model Number: 178091
• Device Catalogue Number: 178091
• Device Lot Number: P0F0721Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1