MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; LHC IN MACS UPPER EXTREMITY PACK

Model Number DYNJ24793L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the lhc detached and fell into the surgical site during an unspecified procedure.Despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional patient, product, or procedural information related to the incident.No adverse patient impact was originally reported.Twenty-five (25) lhc samples were received for investigation.No physical damage or visible defect to the shaft or opening of the lhc were noted.During further inspection, the shaft height and the inner and outer diameter of the opening of the lhc were measured and found to be within the lhc's range tolerance.The lhc appeared to be within specification.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the light handle cover (lhc) detached and fell into the surgical site.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: LHC IN MACS UPPER EXTREMITY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 12462518
• MDR Text Key: 277720183
• Report Number: 1423395-2021-00041
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942389490
• UDI-Public: 10889942389490
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ24793L
• Device Catalogue Number: DYNJ24793L
• Device Lot Number: 21GBF360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other