MAUDE Adverse Event Report: AESCULAP AG S2 1/1-CONT.BOTTOM PERFOR.H118MM H2O2; STERILIZATION CONTAINERS

Model Number JS441

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with js441 - s2 1/1-cont.Bottom perfor.H118mm h2o2.According to the complaint description, the it was reported that sterile containers have been coming out of the wash with a white substance on them.Today the account representative reportedly tried to hand wash the items, then washed them through the washer, also hand wiped the devices and then put them through the washer only to (every time) find a white substance on the devices.One of the devices had so much white substance inside the container that the white substance was caked and fell on the instruments in the set.Reportedly this caused a upcoming procedure to get delayed.The patient was not prepped for surgery yet but due to the reported event one surgeries was delayed as the devices had to be reprocessed using the blue wrap instead the aesculap sterile container.There was no described patient harm.A surgery delay was reported.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00981, 9610612-2020-00982, 9610612-2020-00983.

Event Description

Associated medwatch-reports: 9610612-2020-00980.9610612-2020-00981.9610612-2020-00982.9610612-2020-00983.

Manufacturer Narrative

Investigation results: visual investigation: the products arrived in a decontaminated condition with whitish-gray corrosion.The investigation was carried out visually and microscopically.Investigation leads to the assumption that the whitish gray corrosion was caused by an improper reprocessing.According to the customer brochure, the cleaning instructions must to be observed to avoid this deviation.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: S2 1/1-CONT.BOTTOM PERFOR.H118MM H2O2
• Type of Device: STERILIZATION CONTAINERS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11178136
• MDR Text Key: 227071997
• Report Number: 9610612-2020-00980
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JS441
• Device Catalogue Number: JS441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1