MAUDE Adverse Event Report: TELEFLEX INCORPORATED PILLING; FORCEPS, BIOPSY, BRONCHOSCOPE (RIGID)

Model Number IPN007777

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

Angled cup biter was being used by dr.To obtain a lymph node biopsy.Handle of biter came apart while in use.Instrument was immediately removed from the field.X-ray was obtained prior to surgical incision closure.Absence of retained object was verified by dr.And radiologist.

• Brand Name: PILLING
• Type of Device: FORCEPS, BIOPSY, BRONCHOSCOPE (RIGID)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 15454604
• MDR Text Key: 300246903
• Report Number: 15454604
• Device Sequence Number: 1
• Product Code: JEK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN007777
• Device Catalogue Number: 505106
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female