MAUDE Adverse Event Report: AESCULAP AG FLOW50 INSUFFLATOR W/SMOKE EVACUATION; INSUFFLATION UNITS

Model Number PG150

Device Problems Electrical /Electronic Property Problem (1198); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a flow50 insufflator.According to the complaint description the insuflator presented a error message on the screen "electronic error" during surgery.This error occured several times.The error leaves the equipment locked.It was not possible to use it.This malfunction prolonged the surgery for several minutes.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).This is a similar device report.

Manufacturer Narrative

Investigation results: visual investigation: visually, no deviation can be found at the provided device.According to aesculapo technical service, error code 5532 could refer to an unexpected glass flow.The error must be located in the area of the main or controller board.The proportional valve is closed, the drain valve is also closed, but the output valve is open (but should be closed).Under this circumstances, the insufflator cannot be started.To confirm this assumption, the device was forwarded to the manufacturer.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.No failure of the device was found during investigation.A possible root cause could be external influences on the device.Based upon the investigations results a capa is not necessary.

Manufacturer Narrative

Correction due to incorrect information in the intial report.G4: the 510(k) number was submitted incorrect.Because this is a similar de4vice report and the actual device is not marketed in the us the 510(k) no.Has to remain empty.There is no 510(k) no.Available for this device.

• Brand Name: FLOW50 INSUFFLATOR W/SMOKE EVACUATION
• Type of Device: INSUFFLATION UNITS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10449057
• MDR Text Key: 205704113
• Report Number: 9610612-2020-00456
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K111441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2022

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: PG150
• Device Catalogue Number: PG150
• Device Lot Number: 4511069572
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 02/15/2021; 02/19/2020
• Supplement Dates FDA Received: 03/16/2021; 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1