MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT GOLDLINE,BTN,HOLS,BLADE,15'; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	130326A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this report is being resubmitted following an unsuccessful submission attempt on (b)(6) 2021 due to a system error.Investigation of the customer's complaint of an insufficient heat seal leading to a breach in sterility has confirmed the reported issue.Conmed received one 130326a unopened in original packaging, the reported catalog and lot numbers were verified.A visual inspection found an open hole on the side of the seal.Functional inspection and dye leak testing was not needed as the hole was an obvious breach in sterility.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review 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 97 complaints, regarding 187 devices, for this device family and failure mode.During this same time frame 6,511,230 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (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 connector damage.The ifu also instructs these devices should be inspected before and after each use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, catalog # 130326a lot 201911255, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(6).The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint meets the criteria for a reportable event.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

• Brand Name: GOLDLINE,BTN,HOLS,BLADE,15'
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12385625
• Report Number: 3007305485-2021-00313
• Device Sequence Number: 4892072
• Product Code: GEI
• UDI-Device Identifier: 30653405056243
• UDI-Public: (01)30653405056243(17)241123(10)201911255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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
• Operator of Device: No Information
• Device Expiration Date: 11/23/2024
• Device Model Number: 130326A
• Device Catalogue Number: 130326A
• Device Lot Number: 201911255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1