MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE

Model Number LT-ALC01

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.

Event Description

Aspen surgical received a report from the end user indicating that a light handle cover fell during a procedure.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that a light handle cover fell during a procedure.No injury/death was reported.Sample and manufacturing lot number was available for evaluation.Samples were tested for dimensional accuracy with no issues discovered.Further research found that end users were experiencing issues with the alc covers using trumpf iled7 lights with an slc handle.Aspen's product brochure for the lt-alc01 state that it is for use with trumpf alc surgical light handle models: trulight 5000 and iled 3/5.Per this literature, the alc is not compatible with the iled7 surgical light.Due to this incompatibility with the iled7, this prevents the lt-alc01 cover from fully engaging the snap button on the slc causing the handle to be incorrectly secured.Therefore, the cause can be attributed to off label use by the end user.Light handles identified were used on a surgical light model for which they were not designed or claimed by aspen as compatible.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the end user indicating that a light handle cover fell during a procedure.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).

• Brand Name: ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE
• Type of Device: LIGHT HANDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 9322387
• MDR Text Key: 175240608
• Report Number: 1836161-2019-00093
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• PMA/PMN Number: K020304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT-ALC01
• Device Lot Number: 200523
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1