MAUDE Adverse Event Report: AMBU A/S ISIRIS ALFA

Model Number ALFA01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

During procedure, the operator wanted to grasp the jj catheter after the isiris alfa was introduction into the bladder.The claw of the grasper detached.A second endoscope was then used to retrive the detached claw from the bladder cavity.

Manufacturer Narrative

The reported failure (detached claw) was verified from returned sample.Based on investigation results it is concluded that the grasper claws was activated without having visual control and accidentally hit the jj catheter during grasping which caused it to bend outwards (opening over the opening range) and thereby breaking within the patient.

• Brand Name: ISIRIS ALFA
• Type of Device: ISIRIS ALFA
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69-b; lintang bayan lepas, phase iv; penang, 11900 ; MY 11900
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 17539347
• MDR Text Key: 321148950
• Report Number: 9610691-2023-00019
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 05707480136063
• UDI-Public: 05707480136063
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/14/2023

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
• Device Operator: Health Professional
• Device Model Number: ALFA01
• Device Catalogue Number: ALFA01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• 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 Outcome(s): Other