MAUDE Adverse Event Report: AMBU A/S ISIRIS ALFA

Model Number	ALFA01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610691-2023-00019
• Device Sequence Number: 12316454
• Product Code: FAJ
• UDI-Device Identifier: 05707480136063
• UDI-Public: 05707480136063
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2024
• Device Model Number: ALFA01
• Device Catalogue Number: ALFA01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown