MAUDE Adverse Event Report: FH INDUSTRIE TLS; OPEN STRIPPER

Catalog Number	242049
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Stripper tip fractured during sampling.Patient's current condition: inaccessible foreign body left in place.
Additional Manufacturer Narrative
Fh industrie procedures did not clearly define the rules for reporting incidents to fda when the devices were no longer being distributed into the us market.The vigilance officer at the time was unaware that these reporting rules had to be applied even to products that were no longer distributed in the united states and that were inactivated in the fda registration & listing database.The medwatch reports that were not filed are not connected to any recalls and had no impact on patient safety.A capa was opened to determine root cause and corrective action.

• Brand Name: TLS
• Common Device Name: OPEN STRIPPER
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: el yazid aribi ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 17890223
• Report Number: 3003898228-2023-00010
• Device Sequence Number: 6976241
• Product Code: HWC
• UDI-Device Identifier: 03661489420498
• UDI-Public: 03661489420498
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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: 242049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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