MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRACLEAN 4IN BLADE ELECTRODE WITH EXTENDED INSULATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 139112EXT

Device Problem Delivered as Unsterile Product (1421)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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, ultraclean 4in blade electrode with extended insulation, item 139112ext, lot 201909064, for a possible insufficient heatseal.There was no contact with the patient as this was found during incoming inspection in (b)(4).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 customer's reported complaint of an insufficient heat seal leading to a breach in sterility is confirmed.Conmed received two 139112ext in unopened original packaging, the reported catalog and lot numbers were verified.A visual inspection found the side of seal was not sealed completely on the first device leaving a small gap in the packaging.The second device also had a small section not sealed down completely.A functional inspection was done via dye leak testing per procedure.The dye leak testing found that the packaging of the first device had an insufficient heat seal.The second device did not have an insufficient heat seal.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 92 complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that these devices should never be used when there is visible evidence of damage to the exterior of the device such as cracked or damaged plastic or these devices fail the inspection described.It is also recommended that these devices be inspected before and after each use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRACLEAN 4IN BLADE ELECTRODE WITH EXTENDED INSULATION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 11011987
• MDR Text Key: 222534496
• Report Number: 3007305485-2020-00543
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K991855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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: No Information
• Device Catalogue Number: 139112EXT
• Device Lot Number: 201909064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 11/29/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1