MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 800-SERIES; STERILIZER, STEAM

Model Number 833HC-E

Device Problem Sharp Edges (4013)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by the manufacturing site.Device not returnd to manufacturer.

Event Description

On 13th may, 2020 getinge became aware of a customer product complaint including allegation of sharp edges found on sterilizer's accessories, namely carts designated to be used with 833hc-e sterilizer.The issue was identified on several carts used with four (4) different steam sterilizers of the same model owned by this specific customer.As we were not able to narrow the event to one medical device only, we have decided to report all 4 medical devices separately.There was no injury reported however we decided to report the issue in abundance of caution as usage of carts with exposed sharp edges might bring on a hazardous situation for the user.

Manufacturer Narrative

Getinge became aware of a customer product complaint including allegation of sharp edges found on sterilizer's accessories, namely carts designated to be used with 833hc-e sterilizer.The issue was identified on several carts used with four (4) different steam sterilizers of the same model owned by this specific customer.As we were not able to narrow the event to one medical device only, we have decided to report all 4 medical devices separately.There was no injury reported however we decided to report the issue in abundance of caution as usage of carts with exposed sharp edges might bring on a hazardous situation for the user.The sharp edges on carts were verified by a getinge employee.One of the affected cart was returned to getinge for further evaluation.It was decided that the rework of carts will be done to remove sharp edges at this customer.The repairs are completed and carts could be used without any objections.When reviewing reportable events for this type of issues we were not able to find any similar reportable complaints where the sharp edges on carts used with 833hc-e sterilizers led to any kind of injury.When the event occurred, the device did not meet its specification due to sharp edges were found on carts and contributed to the event.The device was not being used for patient treatment when the event took place.Based on the performed root cause analysis and input from subject matter expert design specification requires supplier to deburr all edges.In this case, some of the edges might have been sharper than expected due to supplier error.Supplier was informed about the problems and implemented corrective actions.We currently do not have any information that would warrant further action towards the devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The purpose of this submission is also to provide a correction of device manufacture date section this is based on the result of an internal review.#h4: previous device manufacture date: 2014-04-23.Corrected device manufacture date: 2014-04-11.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: 800-SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• Manufacturer (Section G): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• Manufacturer Contact: dennis genito ; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 10111338
• MDR Text Key: 217439644
• Report Number: 3012068831-2020-00007
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 833HC-E
• Device Catalogue Number: 8SLVUTHPAAAA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1