MAUDE Adverse Event Report: AESCULAP AG LABORATORY DISH 0.3 L; STERILE TECHNOLOGY

Model Number JG523R

Device Problem Sharp Edges (4013)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

General information it was reported that during the preparation for a surgery (preoperative), an employee of the hospital has cut herself on a sharp edge on one of the products received.Four products (dishes) have been received without packaging in a used condition, decontaminated.Consequences for the patient based on the information available, the damage is considered as temporary damage that will heal fully and will most likely not negatively influence the patient in the future.Investigation the products have been visually checked and pictures were taken with camera and microscope.Furthermore, the edging of all dishes have been manually checked for sharp positions.Two dishes were found to have a sharp spot on the edging; one was only very little and hard to recognize; however, on one dish, the spot was clearly feelable.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: based on the observations and findings made on the returned products as well as the reported information, the issue is most likely related to handling and / or normal wear.Rationale: from all four received dishes, one had an area on the edging which could be identified as "sharp-felt".This is based on the investigation results the one dish which has caused the cut to the employee as reported.The other dishes were not remarkable in regards to sharp edges or areas.All dishes showed signs of usage and wear and tear.No other dish had a sharp area which could be related to the reported issue.During the investigation, it was not possible to identify indicators for material or manufacturing issues that could have led to a sharp edge.Based on those findings and without further information, the area of the sharp edging is very likely caused by regular wear and tear in combination with handling influences (slipping on tray, denting on harder surfaces or even dropping).Corrective action: according to sop (b)(4) (corrective action and preventive action), a capa is not necessary.

Event Description

It was reported that there was an issue with laboratory dish.It was reported that the laboratory trays have a sharp edge where an employee has cut herself slightly.The employee had a temporary impairment.Additional information was not provided nor available / was not available.The adverse event/malfunction is filed under (b)(4).

• Brand Name: LABORATORY DISH 0.3 L
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9977363
• MDR Text Key: 206858956
• Report Number: 9610612-2020-00129
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JG523R
• Device Catalogue Number: JG523R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2020
• 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: Reuse
• Patient Sequence Number: 1