MAUDE Adverse Event Report: AESCULAP AG 3/4-SIZE LID W/RETENTION PLATE SILVERSTERILE TECHNOLOGY

Model Number JK789

Device Problems Residue After Decontamination (2325); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It has been reported that fluff (dark in color) was found inside the containers that have been sterilized.Components in use listed as concomitant devices are: jk789 / 3/4-size lid w/retention plate silver.Jk740 / bottom for 3/4 container height: 90 mm.

• Brand Name: 3/4-SIZE LID W/RETENTION PLATE SILVERSTERILE TECHNOLOGY
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 6754356
• MDR Text Key: 81433746
• Report Number: 9610612-2017-00388
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK789
• Device Catalogue Number: JK789
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/24/2017
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JK740 / BOTTOM FOR 3/4 CONTAINER HEIGHT:90MM; JK789 / 3/4-SIZE LID W/RETENTION PLATE SILVER
• Patient Outcome(s): Other