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

Model Number 178091

Device Problems Detachment of Device or Device Component (2907); Flare or Flash (2942)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic low anterior resection, upon dissecting colon mesentery in operation, tip of black cover sheath melted upon using the cautery device and suction.The doctor did not activate cautery when device was inside the sheath but the cover sheath cannot resist the heat that occurred on the device.It damaged surrounding tissue and some small fragment fell inside patient's body.When doctor saw it melt, the device was immediately changed but it still happen repeatedly with the new opened product.The doctor stopped using it after opening three(3) devices and the problem still happened and used different product.Extended surgical time for more than 30 minutes was noted and there was unnecessary longer expose to anesthetic gas/chemical.

Event Description

According to the reporter, during laparoscopic low anterior resection, upon dissecting colon mesentery in operation, tip of black cover sheath melted upon using the cautery device and suction.Doctor did not activate cautery when device was inside the sheath but the cover sheath cannot resist the heat that occurred on the device.It damaged surrounding tissue and some small fragment fell inside patient's body.When doctor saw it melt, the device was immediately changed but it still happen repeatedly with the new opened product.Doctor stop using it after opening three(3) devices and problem still happened and used different product.Extended surgical time for more than 30 minutes was noted and there was unnecessary longer expose to anesthetic gas/chemical.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the sleeve of the instrument was damaged.It was reported that there was a device related burn and a component disengaged from the device into the surgical cavity.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 11593753
• MDR Text Key: 243092100
• Report Number: 2647580-2021-01146
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 178091
• Device Catalogue Number: 178091
• Device Lot Number: P0E1382Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other