MAUDE Adverse Event Report: AESCULAP AG STEAM STER LOCKS ORANGE; PROCESS INDICATOR LOCK

Model Number US906

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site investigation is on-going.(b)(4).Report of several surgeries delayed; information has not been received.When additional information is received, additional reports will be submitted, as applicable.

Event Description

Country of complaint: usa.Customer reported that following processing of sterilcontainers it was observed that the orange locks dots did not change color.The customer stated that this caused a delay in several surgeries, 10 to 15 minutes.

Manufacturer Narrative

Multiple tests and studies were conducted in an attempt to determine the root cause of the issues being reported by the customer.Light testing: a sample of both lead and lead-free processed locks were placed in a window and exposed to natural light, at the same time, another sample was placed in fluorescent lighting.It was found that excessive exposure to direct sunlight has an adverse effect on lead-free indicators post processing at approximately 4 months and 2 weeks.Although not as pronounced, excessive exposure to fluorescent light has shown to have an effect on lead-free indicators post processing.Capa 16-011 already opened to address this issue.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: PROCESS INDICATOR LOCK
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): SPS MEDICAL; 6789 west henrietta road; rush NY 14543
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5870432
• MDR Text Key: 51941177
• Report Number: 2916714-2016-00723
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US906
• Device Catalogue Number: US906
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/15/2016
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other