MAUDE Adverse Event Report: ARTHREX, INC. FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0'); LIGHT, SURGICAL, FIBEROPTIC

Model Number	FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/21/2022, it was reported by a sales representative via phone that during an laparoscopic procedure on (b)(6) 2022, the distal tip of the ar-3352-5530 laparoscope became hot and burned a hole in the drape.The surgeon used a blue cloth to cover the burned drape.The patient was not harmed and the case was completed by turning off the scope and after a few minutes they were able to complete the case using the same scope.The sales representative was not present during this case and upon arrival the 1/21/2022, was able to collect the device(s) used in the case for evaluation.Additional information requested.Additional information provided 1/24/2022: all part and serial numbers were provided.An image of the drape is also attached.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.See attached: attached investigation report states: during the investigation light guide has extreme multiple broken fibers from customer damage.Extreme broken fibers cause low light output.

• Brand Name: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19561289
• Report Number: 1220246-2024-05994
• Device Sequence Number: 7550609
• Product Code: FST
• UDI-Device Identifier: 00888867029408
• UDI-Public: 00888867029408
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K901035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• Device Catalogue Number: AR-3240-5027
• Device Lot Number: WO178191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown