MAUDE Adverse Event Report: AMBU A/S ISIRIS ALFA; SINGLE USE CYSTOSCOPE

Model Number	ALFA01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample not yet received for investigation.Investigation performed on retention sample from same lot.Grasper pull force test was performed according to verification protocol.The grasper of the retention sample passed test without breaking.It is concluded that the grasper jaws meet the specification and function as intended.Based on the reported failure and that attempts were made to remove stent, it is suspected that the grasper was active and the grasper jaws accidentally hit the bladder wall causing the grasper to bent outward, opened over the opening range and thereby broke.Ifu includes warning and cautions to prevent damage to grasper.
Event or Problem Description
During an attempt to remove a stent with an isiris cystoscope, the operator had difficulties to remove the stent, the grasper of the scope, and dislodge to patient's bladder.A flexible cystoscope was used to retrieve the grasper in the bladder cavity and to remove the stent.The procedure was prolonged with 30 minutes.No harm to patient.

• Brand Name: ISIRIS ALFA
• Common Device Name: SINGLE USE CYSTOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN.BHD; lintang bayan lepas, phase iv; lot 69-b; penang, 11900 0; MY 119000
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16276635
• Report Number: 9610691-2023-00002
• Device Sequence Number: 15128721
• 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): 01/31/2023

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 Model Number: ALFA01
• Device Catalogue Number: ALFA01
• Device Lot Number: 1000474163
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (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: Required Intervention
• Patient Sex: Unknown