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

Catalog Number 50004

Device Problem Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Neck Pain (2433); No Code Available (3191)

Event Date 04/28/2015

Event Type  Injury  

Event Description

A customer reported that three healthcare workers (hcws) are stating the design of the evotech¿ is causing them to have back pain.The symptoms occur with the loading and unloading of their scopes.This report is for healthcare worker m.(b)(6).She is 5'7" tall and reports having shoulder and neck pain.She experiences these symptoms while loading scopes and making scope connections.She is currently wearing a back brace.The hospital¿s occupational staff is working with her for ergonomic solutions.1-(b)(4) are related complaints from the same facility.This is two of three 3500a reports being submitted.Please reference manufacturer report numbers: 2084725-2015-00111, 2084725-2015-00112 and 2084725-2015-00113.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Manufacturer date: 05/24/2013.Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, failure mode effects analysis (fmea), and system risk analysis (sra).The dhr (device history record) was reviewed and indicated the unit met specification at the time of its release.The service history for this unit for the past 6 months (11/02/2014 ¿ (b)(6) 2015) did not reveal a significant trend.The complaint trending for problem code ¿human reaction¿ over the past 12 months (june 2014 ¿ (b)(6) 2015) did not reveal a significant trend.The fmea (failure mode effects analysis) indicates the rpn for this issue is within limits.The sra (system risk analysis) shows the risk for "exposure to mechanical or physical force" to be low.The cause of the injury can not be verified.The unit meets functionality.Further investigation shows a heavy workload of processing scopes at this facility.Therefore, no assignable cause can be determined.The issue appears to be isolated to this facility.However, this issue will continue to be monitored.

• 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: 4806547
• MDR Text Key: 18895518
• Report Number: 2084725-2015-00112
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• 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: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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