MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCEFX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number FORCEFX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558)

Event Date 07/29/2017

Event Type  Injury  

Event Description

According to the literature, a study to evaluate the rate of perioperative complications after plasmakinetic bipolar and monopolar t ransurethral resection of bladder tumor (bturb and mturb) in four hundred twenty-seven patients met inclusion criteria and underwent 586 procedures (379 bturb and 207 mturb).In addition, the study identifies patient and procedure characteristics associated with e arly complications.Retrospective review was conducted on patients undergoing transurethral resection of bladder tumor procedures at a single institution from 2003 to 2013 to assess the 30-day complication rates associated with bturb and mturb.Complications were hematuria, acute urinary retention (aur) and urinary tract infection (uti).2 patients in the monopolar turb group (force fx generator) required transfusion.The 21 cases of extraperitoneal perforation were managed with urethral catheter bladder decompression, and the single case of intraperitoneal perforation (after bturb) was managed with laparotomy and cystorrhaphy.Title: ten-year review of perioperative complications after transurethral resection of bladder tumors: analysis of monopolar and pla smakinetic bipolar cases author: michael a.Avallone date of publication: 01-august-2017.

Manufacturer Narrative

Title: en-year review of perioperative complications after transurethral resection of bladder tumors: analysis of monopolar and plasmakinetic bipolar cases source: journal of endourology volume 31, number 8, august 2017.Concomitant medical product/s: forcefx forcefx discon use forcfx-8 lot/serial #:unknown.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: FORCEFX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15329340
• MDR Text Key: 298999929
• Report Number: 1717344-2022-01054
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFX
• Device Catalogue Number: FORCEFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male