MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MAJOR ABDOMINAL/GENERAL-LF

Catalog Number	CDS984534G
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a right total hip arthroplasty procedure on 10/26/2020 the device an ultra coated cautery tip, (part of an major abdominal pack) was being utilized to control bleeding.Reporter states the tip broke and "most likely stayed inside a patient." it had initially been reported that multiple x-ray films were taken during the procedure and it was not noted during those films." the reporter states, "the surgical site was searched for the broken tip, the surgeon performed 3 washouts in an attempt to flush out the tip.No tip was found." the sample has been return for evaluation.Investigation summary: the account reported finding: cautery tip broke during use.The reported issue occurred in item cds984534g (lot 20fda669).Due to the fact that we do not alter this component during the kitting process this is considered a vendor product issue.Actions taken and recommendations: this complaint has been provided to the vendor for further evaluation.Our supplier quality team will also monitor this issue for trending purposes." due to the reported medical intervention and in abundance of caution, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported during a procedure a cautery tip broke and "most likely stayed inside a patient.".

• Common Device Name: MAJOR ABDOMINAL/GENERAL-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10885541
• Report Number: 1423395-2020-00033
• Device Sequence Number: 2705836
• Product Code: LRO
• UDI-Device Identifier: 10193489364330
• UDI-Public: 10193489364330
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: Health Professional
• Device Catalogue Number: CDS984534G
• Device Lot Number: 20FDA669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 92