MAUDE Adverse Event Report: GETINGE DISINFECTION AB WD 15 CLARO; MEC

Model Number GE15

Device Problems Material Integrity Problem (2978); Scratched Material (3020)

Patient Problem Laceration(s) (1946)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon results of the investigation.

Event Description

On (b)(6) we were informed by the getinge representative about an incident where as stated, the technician was injured.During reassembling of the heating elements in ge15 device the technician cut his finger.The incident was caused by the sharp edges on the clamps that holds heating elements at place.

Manufacturer Narrative

This report is being filed under exemption (b)(4) by the manufacturer getinge disinfection (b)(4), (registration no.(b)(4)) on behalf of the importer (b)(4)., (registration no.(b)(4)).The event is being investigated.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

An investigation was performed on this complaint.(b)(4) received a complaint where it was indicated that the technician cut his finger on the clamp holding heating elements in wd15 tabletop washer disinfector.When reviewing reportable events for this device we were able to establish that this issue is considered as a single, isolated event.Compared to the number of the devices produced (about(b)(4) devices since start of the production in april 2009) the occurrence rate for the complaints with this failure is considered to be very low.At the time as the incident occurred the device has been repaired by the technician to address an unrelated issue of the failure of a heating element.The technician injured his finger, while opening a clamp to remove broken heating part.The device was not up to the manufacturer specification when the event took place and was directly involved in the reportable event.The clamps assembled into the getinge machines are parts provided by the supplier 3d-mechanics as an "off the shelf" product.The current stock of clamps on the production facility was checked and it was confirmed that none of the available clamps appeared to have sharp edges, moreover we did not find any similar case, where these clamps would have sharp edges and could cause such injury.Therefore we could assume that this is rather isolated than systematic issue.As confirmed with the supplier, clamps edges should have been checked before delivery to the (b)(4) facility, all sharp edges shall be removed.Based on the collected information it has been concluded that most likely root cause of the failure is connected with supplier who has not checked or removed the sharp edges before the delivery of the clamp.The device was not being used for patient care at the time of the event, the device appears not to have been to specification and contributed to the event with the service technician.(b)(4).This report is being filed under exemption (b)(4) by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer (b)(4).

Manufacturer Narrative

(b)(4).We have detected new information and hereby correct our report.We reported previously that the defective part - a clamp - was delivered by a supplier.This was reported in error.We now confirm the part to have been produced on-site by our in-house manufacturer of the device between 2010 and 2012.At this time the clamps were cut by laser.The application of this technique should normally not need any remediation work afterwards since no sharp edges would normally be appearing.The production of the clamps was moved to the supplier in 2012.Since then clamps are ordered from the supplier as on the shelf product.We have not found the root cause of the allegation of the clamp having been sharp.Looking at the fact that it was a single isolated event, with very low possibility for reoccurrence we concluded currently not to propose any further actions.

• Brand Name: WD 15 CLARO
• Type of Device: MEC
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, sweden 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, sweden 35115 ; SW 35115
• Manufacturer Contact: ann wheeler ; 1777 e. henrietta road; rochester, NY 14623 ; 5852725036
• MDR Report Key: 6075175
• MDR Text Key: 59010600
• Report Number: 9616031-2016-00007
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2017,03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Service Personnel
• Device Model Number: GE15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2017
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2017
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2010
• 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
• Patient Outcome(s): Other