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

Model Number	ALFA01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample returned for investigation.The reported failure was verified from the returned sample.Visual inspection performed using mircroscope.No dents or corrosion identified that could cause grasper to brake.Grasper pull force test was performed according to verification protocol on 3 retention smaple.The grasper of the retention samples passed test without breaking.It is concluded that the grasper jaws meet the specification and function as intended.Simulation test was done on order to break the grasper joint by activating the grasper and forcing it on a flat surface.When forcing the grasper joint over the opening rang the grasper would brake.Based on the reported failure and he investigation results it is suspected that the grasper was actived and forced opened outside the opening range.Ifu includes warning and cautions to prevent damage to grasper.
Event or Problem Description
During procedure the lower part of the cystoscope's grasper fbroke and dislodged into the patient's bladder.Grasper was removed using another cystoscope.Patient outcome not affected.

• Brand Name: ISIRIS ALFA
• Common Device Name: SINGLE USE CYSTOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; baallerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN.BHD; lintang bayan lepas, phase iv; lot 69-b; penang 11900 ; MY 11900
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16395745
• Report Number: 9610691-2023-00005
• Device Sequence Number: 6433270
• Product Code: FAJ
• UDI-Device Identifier: 05707480136063
• UDI-Public: 05707480136063
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 02/17/2023

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: 100474163
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 02/17/2023
• 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: Other
• Patient Sex: Unknown