MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN PROTACK

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Foreign Body Reaction (1868); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

Title: collateral damage of wandering protacks source: lower urinary tract symptoms.2022;1¿4 accepted: (b)(6) 2022.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.

Event Description

According to the literature source of study, on post operative inguinal hernia surgery 20 years prior, a 75 year old male experience obstructive lower urinary tract symptoms due to a tack that had detached and migrated into the bladder.The patient underwent a flexible cystoscopy and computed tomography (ct) urography which showed a small stone.The patient underwent re-do transurethral resection of the prostate (turp) and stone removal.When the stone was removed, the tack was revealed which was unable to be retrieved.The stone was formed from calcifications surrounding the tack.The patient presented a month later, with abdominal pain and underwent contrast abdominal ct scan which showed multiple tacks along the left anterior abdominal wall.The patient was diagnosed with intestinal obstruction due to adhesions from the staples from the previous hernia surgery.The obstruction was managed conservatively and spontaneously resolved.

• Brand Name: UNKNOWN PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15928211
• MDR Text Key: 304954718
• Report Number: 2647580-2022-04467
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROTACK
• Device Catalogue Number: UNKNOWN PROTACK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male