MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR; EVOTECH EQUIPMENT

Catalog Number 50004

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fall (1848); Sprain (2083); Swelling (2091)

Event Date 07/13/2015

Event Type  Injury  

Event Description

A customer reported a healthcare worker (hcw) slipped and fell on fluid leaking from an evotech endoscopic cleaner and reprocessor and injured her left knee.Her symptoms included swelling and pain to the left knee.The healthcare worker was seen in the hospital emergency room.X-rays were taken and showed a sprain to the knee cap.There were no fractures.The healthcare worker sought a second opinion with an orthopedic surgeon, and the orthopedic surgeon confirmed there were no issues with the ligament and was prescribed physical therapy.The healthcare worker was prescribed medications for swelling and pain that included tramadol and diclofenac sod, metoclopramide, paracetamo orphenadrine, and ketotop plaster.The healthcare worker resumed work after four days off medical leave.

Manufacturer Narrative

Manufacturer date: 11/25/2009.Asp investigation summary: the investigation included a review of the device history record (dhr), service history record, trending of the product malfunction code and system risk analysis (sra).¿ the dhr was reviewed and the unit met manufacturer specifications at the time of release.No issues were related to this failure mode.¿ the service history for the past six months was reviewed from 1/16/2015 to 7/15/2015 and did not identify any significant trend.¿ trending analysis for the product malfunction code of ''human reaction" was reviewed from may 2014 through july 2015 and no significant trend was observed.¿ the sra was reviewed for the issue of "human reaction" with "exposure to mechanical or physical force" and the risk was determined to be low.A field service engineer was dispatched to the site.The pressure relief valve was replaced to repair the leak.The part was not returned for evaluation.After service and repair, the met system specifications.The reported issue was resolved at the customer facility.The issue will be tracked and trended.No further investigation is necessary at this time.

• Brand Name: EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR
• Type of Device: EVOTECH EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: cecil navajas ; irvine, CA 92618 ; 7863138802
• MDR Report Key: 4993664
• MDR Text Key: 22634816
• Report Number: 2084725-2015-00208
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K040883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/13/2015

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 Catalogue Number: 50004
• Device Lot Number: 5040308003
• Other Device ID Number: 50004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• 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): Required Intervention