FDA Adverse Event Malfunction Summary report: N

ASCOPE¿ 5 BRONCHO HD 5.0/2.2 SAMPLER SET

MDR report key: 23187766 · Received October 1, 2025

Report

Report Number
23187766
Event Type
Malfunction
Date Received
October 1, 2025
Date of Event
August 15, 2025
Report Date
September 9, 2025
Manufacturer
AMBU INC.
Product Code
EOQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT [REDACTED] IN FOR AN OUTPATIENT BRONCHOSCOPY WITH WASHINGS, BRUSHINGS, AND POSSIBLE BIOPSY UNDER GENERAL ANESTHESIA (WITH A LMA [LARYNGEAL MASK AIRWAY]) DUE TO LEFT LOWER LOBE INFILTRATES, CONSOLIDATION, AND MASS. PROCEDURE PERFORMED BY DR. [REDACTED]. PT WAS IN THE ROOM BY 0745, PROCEDURE STARTED AT 0757 AFTER A PAUSE AT 0756. PROCEDURE WAS GOING AS PLANNED, AFTER TWO LAVAGES AND MULTIPLE WASHINGS DUE TO MUCOUS PLUGGING, MD STATED HE WOULD LIKE TO GET A BRUSHING OF LEFT LOWER LOBE. WRITER OPENED BRUSHING PACKAGE, VISUAL INSPECTION OF BRUSH WAS COMPLETED, AND BRUSH WAS HANDED TO DR. [REDACTED]. MD INSERTED BRUSH INTO BIOPSY CHANNEL AS USUAL, BRUSH WAS OBSERVED COMING OUT OF BIOPSY CHANNEL AT END OF SCOPE INSIDE THE BRONCHIAL, AFTER MD INSTRUCTED WRITER TO DEPLOY BRUSH OUT, BRUSH WAS DEPLOYED, AND UPON BRUSHING COMING OUT OF SHEATH COVER, WRITER, DR. [REDACTED], DR. [REDACTED], AND [REDACTED] NOTICED SOMETHING WHITE TO THE LEFT SIDE OF SCREEN, NEXT TO BRUSH. ONCE BRUSH WAS RETRACTED, AND REMOVED FROM BIOPSY CHANNEL, AN OBVIOUS WHITE PIECE OF FOREIGN BODY WAS NOTED INSIDE THE BRONCHUS. MD ATTEMPTED RETRIEVAL WITH A BIOPSY FORCEP, WHICH FAILED, MD NOTED THAT FORCEP WAS DIFFICULT TO ADVANCE INTO BIOPSY CHANNEL, MD DID A VISUAL INSPECTION OF THE BRONCHOSCOPE AND ASKED FOR A NEW SCOPE, MD SUSPECT FOREIGN BODY MAY BE A PIECE OF THE SCOPE. WITH A NEW SCOPE AND AN AIRWAY RETRIEVAL BASKET, FOREIGN BODY WAS RETRIEVED AND WAS PLACED INTO A SPECIMEN CUP. AT THIS TIME, MD NAMED THE FOREIGN BODY AN "IATROGENIC FOREIGN BODY". BRUSHING WAS COMPLETED AND AFTER MORE WASHING, PROCEDURE WAS COMPETED AT 0825. PT WAS EXTUBATED AND TAKEN TO PACU [POST ANESTHESIA RECOVERY UNIT]. UPON FURTHER INSPECTION OF BRONCHOSCOPE BY DR. [REDACTED] AND [REDACTED], A PIECE OF PLASTIC ON THE BIOPSY CHANNEL CAP WAS NOTED TO BE MISSING, WHEN COMPARED TO ANOTHER INTACT BIOPSY CHANNEL CAP. FOREIGN BODY APPEARS TO BE "HALF-MOON" SHAPE, WHICH MATCHES MISSING PIECE OF BIOPSY CHANNEL CAP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2154407 ASCOPE¿ 5 BRONCHO HD 5.0/2.2 SAMPLER SET BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ AMBU INC. 621002000US 1001156886

Patients

Seq Age Sex Outcome Treatment
1 75 YR Unknown