MAUDE Adverse Event Report: AESCULAP AG SINGLE USE PAPER FILTER WITH INDICATOR STERILE TECHNOLOGY

Model Number JK095

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report. Manufacturing site evaluation: this is a preliminary report. Only photos are available for the investigation from quality management and the products were sent to the manufacturer for an analysis. Investigation - there were visible holes in the filter. Batch history review - the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause - only photos are available and it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale - this report will be updated when we receive a statement from the manufacturer. According to the quality standard and dhr files a material defect and production error can be excluded. Due to a similar error pattern in other complaints, there is the possibility that the holes were created mechanically by an object or by faulty handling.

Event Description

It was reported that there was an issue with a couple single use paper filters. It was noticed that the filter paper in an instrument container had small holes, and the set was rejected due to concern about sterility. When reviewing the rest of the batch, it was possible to verify that there were more filters with the same defect which were not used. It was noted that the malfunction with the set was found prior to a procedure in the safety clinic and the scheduled surgery was postponed. On 21jan2019 additional clarification was received. It was confirmed that the procedure had not yet started, the patient was not under anesthesia, and there was no surgical delay. This report refers to the filter in the surgical instrument set: 9610612-2019-00048.

Manufacturer Narrative

(b)(4). Exemption number: e2014018. No known patient history. Pma/510k: k944864: reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S.

• Brand Name: SINGLE USE PAPER FILTER WITH INDICATOR
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8290694
• MDR Text Key: 136922199
• Report Number: 9610612-2019-00023
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: JK095
• Device Catalogue Number: JK095
• Device Lot Number: 4509477053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 01/09/2019
• Device Age: 9 MO
• Event Location: No Information
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 01/30/2019 Patient Sequence Number: 1

Treatment

INSTRUMENT CONTAINER