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

Model Number ALFA01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 308860448
• Report Number: 9610691-2023-00002
• 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: 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
• Device Operator: Health Professional
• Device Model Number: ALFA01
• Device Catalogue Number: ALFA01
• Device Lot Number: 1000474163
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention