MAUDE Adverse Event Report: GYRUS ACMI, INC TFL LASER US STANDARD POWER CORD

Model Number	TFL-APCUS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed by the biomedical engineer at the user facility via telephone that the strain relief on the tfl laser us standard power cord is reportedly "damaged causing exposed wire" and requested a replacement.No patient injury or harm was reported to olympus.
Additional Manufacturer Narrative
The technical support engineer provided the biomedical engineer with the part number for the replacement cord.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4 - unknown as the lot number was not provided.The dhr was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, the specific root cause of the damaged power cord could not be determined at this time.The following information is stated in the instructions for use which may have detected the event: "before connecting the soltive laser system components, inspect the individual components, cables, and electrical connections for dirt, debris, or damage.Verify that the electrical cables are not frayed or split.Contact your local olympus service representative if any component appears damaged.".Olympus will continue to monitor field performance for this device.

• Brand Name: TFL LASER US STANDARD POWER CORD
• Common Device Name: POWER CORD
• Manufacturer (Section D): GYRUS ACMI, INC; 137 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13298967
• Report Number: 3003790304-2022-00015
• Device Sequence Number: 20032911
• Product Code: GEX
• UDI-Device Identifier: 00821925044463
• UDI-Public: 00821925044463
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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 Model Number: TFL-APCUS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown