MAUDE Adverse Event Report: AESCULAP AG S2 1/2-CONTAINER LID H2O2; STERILE TECHNOLOGY

Model Number JS389

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/02/2020

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 js389 - s2 1/2-container lid h2o2 according to the complaint description, it was reported that white powder was inside and outside of container.There was no described patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00754 (b)(4).

Manufacturer Narrative

Updated d4, d9: udi, date of device returned to manufacturer.Updated e2: health professional.Updated h6: codes.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: visual investigation: the products arrived in a decontaminated condition with whitish-gray corrosion.The investigation was carried out visually and microscopically.Here we detected a whitish gray corrosion of the product.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.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 product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.

Event Description

Associated medwatch-reports: 9610612-2020-00754 (400487385 - js340), 9610612-2020-00755 ( 400487386 - js389).

• Brand Name: S2 1/2-CONTAINER LID H2O2
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10837697
• MDR Text Key: 249643633
• Report Number: 9610612-2020-00755
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193582
• 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: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JS389
• Device Catalogue Number: JS389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1