MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. MEDICHOICE VESSEL LOOPS; MINI RED

Catalog Number LOOP2004

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Aspen surgical received a report from our distributor indicating that vessel loops packages were discovered with sealing issues.Customer alleged that sterility concern was not noticed until after some were utilized in procedures.No injury/death was reported.This is entered in our system as (b)(4).

Manufacturer Narrative

Aspen surgical recieved a report from the distributor indicating that product was found with seal issues.The actual device will be returned for evaluation.The manufacturing lot numbers were provided for review.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.

• Brand Name: MEDICHOICE VESSEL LOOPS; MINI RED
• Type of Device: VESSEL LOOPS
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 18783218
• MDR Text Key: 336409349
• Report Number: 3002750084-2024-00004
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2024

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 Catalogue Number: LOOP2004
• Device Lot Number: 343301, 316564
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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