MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA VESSEL LOOPS, BLUE, MAXI, STERILE

Model Number 011012PBX

Device Problem Defective Component (2292)

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

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was returned for evaluation.Photographic evidence along with the manufacturing lot number were also provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the photos and sample confirmed the issue from the distributor.Analysis of the finished good lot number was reviewed.No non-conformance's were noted during the manufacturing process.According to the manufacturing process, these parts are loaded into a sealer per specified work instructions.The parts are then inspected for any seal discrepancies for verification by the operator.Therefore, the likely root cause is attributed to operator error.Production team was notified of the event.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a vessel loop was found with defective seals.The item was not in use.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).

• Brand Name: VESSEL LOOPS, BLUE, MAXI, STERILE
• Type of Device: VESSEL LOOPS
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 10958360
• MDR Text Key: 220755152
• Report Number: 1836161-2020-00060
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 011012PBX
• Device Lot Number: 216603
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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