MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK APPLIER ENDO 5MM MEDIUM-LARGE; APPLIER, SURGICAL, CLIP

Catalog Number 544965TR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/03/2024

Event Type  Injury  

Event Description

It was reported "whilst using the applier, the applier broke in the abdomen of the patient.Several small fragments were recovered." the patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).

• Brand Name: HEMOLOK APPLIER ENDO 5MM MEDIUM-LARGE
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19187847
• MDR Text Key: 341116276
• Report Number: 3011137372-2024-00065
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965TR
• Device Lot Number: P2201218
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female