MAUDE Adverse Event Report: AESCULAP AG FOOT FOR PERFORATED BASKETS; PERFORATED BASKETS (JF, JG, JH)

Model Number JF112210

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: usa.Materials director reported: black flecks were found in several sets that were housed in aesculap sterile containers, as well as baskets wrapped in disposable wrap.Cases were cancelled over patient safety concerns.Immediate suspect was the peek feet on the container baskets.Pictures and samples (peek feet removed from basket) were taken and will be forwarded to aesculap qa.Additional concerns include water supply lines, adequate and properly maintained filters for washers and autoclaves.Independent lab testing in progress to determine the makeup of the black flecks.Did occur during surgery, no harm to patient, surgical delay (21 cases were cancelled on wednesday, (b)(6) 2018 and 4 additional eye cases cancelled on thursday, (b)(6) 2018 when additional black flecks were found in reprocessed sets).Update from materials director: no patient was under anesthesia at the time, although iv's were in place on some patients.

Manufacturer Narrative

A visual inspection was performed.The surface of the feet are worn, scratches can be found all over the surface.Several holding brackets are broken off.Flashings between the segments can also be found on all the provided feet.Batch history review the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause based on the information available as well as a result of our investigation the root cause of the failure is most probably related to a manufacturing material error.Rationale the breakage of the holding brackets were most likely caused by a drop or an impact during handling of the baskets.No capa necessary.

Manufacturer Narrative

Upon further review, a capa had been opened.Aesculap will continue to track and trend for issues of this nature and take appropriate action for future recurrence.

• Brand Name: FOOT FOR PERFORATED BASKETS
• Type of Device: PERFORATED BASKETS (JF, JG, JH)
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7704566
• MDR Text Key: 114721456
• Report Number: 9610612-2018-00321
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JF112210
• Device Catalogue Number: JF112210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Distributor Facility Aware Date: 08/23/2018
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other