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 07/06/2023

Event Type  malfunction  

Event Description

During pre-check, the doctor operating isiris alfa scope confirmed the functionin of the grasper and claimed it was in a good condition.During the procedure, the doctor felt slight resistance in the bladder using the scope.Then, one side of the rat tooth grasper came off in the bladder cavity of the patient.The doctor then had to use another ambu scope with a separate grasper to retrieve the part of the grasper that broke off in the patient.Patient outcome was not affected.

Manufacturer Narrative

Sample was not returned for investigation, therefore the investigation was performed on a retention sample.Retention sample passed the visual inspection as the grasper jaws were in good physical condition when activated and the grasper functioned as intended.Pull force test was performed according to the verification protocol and it concluded that the grasper jaws meet the specification, since no abnormalities were observed and the grasper functioned as intended.Based on the reported failure, a simulation of breaking the grasper was performed and it showed that when opened over the opening range, it causes the jaws to bent outward and break.Ifu includes warning and cautions (section 1.4, caution 5 and 7) to prevent damage to grasper.Based on the investigation results, it is suspected that the grasper jaws were activated and accidentally hit bladder cavity wall, which corresponds with the reported resistance felt by the operator.This lead to the outward bending of the jaw as it was pushed forward and eventually to it's breaking.We will continue to monitor this type of failure.

• 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 69b; lintang bayan lepas 6, phase i; penang, 11900 ; MY 11900
• Manufacturer Contact: lenka vaculciakova ; baltropbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 17434992
• MDR Text Key: 320141152
• Report Number: 9610691-2023-00018
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K160766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALFA01
• Device Lot Number: 1000568370
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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