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

Catalog Number 50004

Device Problem Chemical Problem (2893)

Patient Problems Irritation (1941); Respiratory Distress (2045); Sneezing (2251); Chest Tightness/Pressure (2463); Chemical Exposure (2570); No Code Available (3191)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

Since the source of the vapors in the room cannot be clearly identified and the evotech® ecr and cidex opa-c solution were both used in the room, asp has decided to report this event out of an abundance of caution.(b)(4) are related complaints from the same facility.This is two of seven 3500a reports being submitted for this serious injury.Please reference manufacture report numbers: 2084725-2016-00032, 2084725-2016-00033, 2084725-2016-00034, 2084725-2016-00035, 2084725-2016-00036, 2084725-2016-00037, 2084725-2016-00038.(b)(4).

Event Description

A customer reported seven (7) healthcare workers are experiencing respiratory symptoms and eye irritation from vapors in the endoscopy room of their facility.They state they are unsure what is causing the vapors in the room, and it is uncertain whether or not a chemical spill contributed to this.The customer also reported there is poor ventilation in the room and are investigating this.The room consists of two evotech endoscopic cleaner and reprocessors (ecrs) with cidex opa-c solution that is contained within the unit.In addition, the customer reports they manually soak and clean their instruments using metricide opa solution in an open basin prior to putting in the evotech ecr.An advanced sterilization products (asp) field service engineer (fse) was dispatched to the site to inspect and service the evotech ecr units.No problems were found with the units and no odor was detected.This is a report for healthcare worker (hcw) #2 who reports symptoms of nasal congestion, sneezing, hoarseness, coughing, and shortness of breath, bronchospasms and wheezing.She reports itching of the eyes and throat and tingling of the lips every time she entered the scope room.The symptoms began around (b)(6) 2015.She was seen in the emergency room of the hospital and was prescribed albuterol, symbicort and prednisone.She was hospitalized (b)(6), 2015 due to a drug reaction from a high dose of prednisone to treat her respiratory symptoms that are still ongoing.The healthcare worker reports personal protective equipment (ppe) of a gown, gloves, eye wear, and a mask is worn while performing their job duties.

Manufacturer Narrative

Corrected data: it was initially reported there were seven (7) healthcare workers experiencing symptoms.It was later reported there was one additional healthcare worker who reported symptoms.This is captured on pi 1-sntcyg, manufacture report number 2084725-2016-00079.Corrected usage of device from "initial usage of device" to "reuse".Asp investigation summary: the investigation included a review of the device history record (dhr) 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 sra was reviewed for the issue of "respiratory reaction" with "exposure to toxic and corrosive material" and the risk was determined to be low.The sra was reviewed for the issue of "eye reaction" with "exposure to toxic and corrosive material" and the risk was determined to be low.Upon further follow-up, the customer states the following steps were taken to resolve the issue: the air ventilation system in the room was re-vented to the outside which increased the air exchanges in the room from 10 to 17 per hour.The air exchanges were measured and found to be within specification.An industrial hygienist was contracted in (b)(4) 2016 to review and evaluate their processing procedures and meet with each healthcare worker to ensure proper procedures are being followed.The customer states they are no longer experiencing issues.No problem could be found in regards to the functionality of the evotech¿ ecr.The likely assignable cause can be attributed to poor ventilation, however, this could not be verified.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: joaquin kurz ; irvine, CA 92618
• MDR Report Key: 5377509
• MDR Text Key: 36338432
• Report Number: 2084725-2016-00033
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 50004
• Other Device ID Number: 50004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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): Hospitalization
• Patient Age: 34 YR