MAUDE Adverse Event Report: CONMED CORPORATION ELIMINATOR ESOPHAGEAL PET BALLOON DILATOR; DILATOR, ESOPHAGEAL

Catalog Number 000344

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At time of filing, although expected, the reported device has not been returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

During incoming inspection, the distributor rejected this device, eliminator esophageal pet balloon dilator, catalog # 000344 lot 201912021, for a possible insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(6).Due to the potential severity of a possible breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The distributor rejected the product due to a possible insufficient heatseal leading to concerns of breach in sterility, however please note, upon further review, it has been determined that this device is packaged and shipped as a non-sterile device.If an insufficient heatseal had been confirmed, there would have been no potential for breach in sterility as the device is non-sterile.The customer's reported complaint of an insufficient heat seal leading to a breach in sterility is unconfirmed.Conmed received four 000344 in unopened original packaging, the reported catalog and lot numbers were verified.A visual inspection was unable to find any obvious seal breaches, abnormalities or defects.A two-year lot history review shows this is the only complaint, with 4 units, for this lot number and failure mode.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ELIMINATOR ESOPHAGEAL PET BALLOON DILATOR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 10516632
• MDR Text Key: 207543278
• Report Number: 1320894-2020-00381
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K033936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 000344
• Device Lot Number: 201912021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1