MAUDE Adverse Event Report: XODUS MEDICAL INC. ELECTROSURGICAL TIP CLEANER 40/CS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	138029
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 07/27/2021 due to a system error.Voluntary distributor report narrative: device will be forwarded to the manufacturer, xodus.The manufacturer, xodus., is responsible for performing evaluation, investigation and any remedial actions related to this reported device issue per agreement with conmed corporation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This is a voluntary distributor report during incoming inspection, the distributor rejected this device, catalog # 138029 lot 19mar14a, 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 preliminary device evaluation confirmed an insufficient heatseal; therefore, this complaint meets the criteria for a reportable event.This report is being raised as a voluntary distributor report on the basis of device malfunction with potential for injury upon reoccurrence.

• Brand Name: ELECTROSURGICAL TIP CLEANER 40/CS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): XODUS MEDICAL INC.; westmoreland business & resear; 702 prominence drive; new kensington PA 15068
• MDR Report Key: 12387379
• Report Number: 1320894-2021-00326
• Device Sequence Number: 17301721
• Product Code: GEI
• UDI-Device Identifier: 00787551000535
• UDI-Public: (01)00787551000535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K874775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• 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: 02/01/2024
• Device Catalogue Number: 138029
• Device Lot Number: 19MAR14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/30/2021
• Patient Sequence Number: 1