MAUDE Adverse Event Report: MAQUET GMBH PAIR OF PIVOT-MOUNTED ELONGATION TUBES; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100259A0

Device Problem Sharp Edges (4013)

Patient Problems Abrasion (1689); Unspecified Tissue Injury (4559)

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Event site name (e1): dr.Lubos klinik bogenhausen h3 other text : device not returned to manufacturer.

Event Description

On (b)(6), 2023 getinge became aware of an issue with one of our accessories ¿ 100259a0 - pair of pivot-mounted elongation tubes.As it was stated and confirmed with the photographic evidence, the elongation tube was defective with splintered off metal.The issue has led to the injury of the anesthesiologist.According to the provided information, no medical intervention was required.We decided to report the issue based on the potential for serious injury if the situation, namely the damaged surface leading to the injury of the user due to sharp edge, was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with one of our accessories ¿ 100259a0 - pair of pivot-mounted elongation tubes.As it was stated and confirmed with the photographic evidence, the elongation tube was defective with splintered off metal.The issue has led to the injury of the anesthesiologist.According to the provided information, no medical intervention was required.We decided to report the issue based on the potential for serious injury if the situation, namely the damaged surface leading to the injury of the user due to sharp edge, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, it is unknown if the device was being used for the patient¿s treatment, however, was directly involved with the reported incident.As the malfunction was proved by the photographic evidence, it was considered that the getinge device was not up to the specification.A review of the received customer product complaints revealed that there were no serious injuries to a user nor to a patient or operator when this particular issue occurred.The complaint investigated herein is a single and isolated case.Based on the information provided by the company¿s sales person the affected getinge device has been replaced.The subject matter expert (sme) has established that there is a splint, most likely from a defect in the tube weld seam of the raw material of the anesthesia screen.The devices were assembled at supplier apo maquet.Based on the quality assurance agreement, the supplier is responsible for functional checks and all other relevant quality checks.In summary and as a result of the performed root cause evaluation, it can be suspected that the most probable root cause of the reported issue, namely the anesthesiologist injuring themselves due to the splintered off metal on elongation tube, is related to manufacturing process at supplier¿ site.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The correction of h6 health effect ¿ clinical code field deems required.This is based on the internal evaluation.Previous h6 health effect ¿ clinical code: injury|abrasion||1689.Corrected h6 health effect ¿ clinical code: injury|unspecified tissue injury||4559.

Event Description

Manufacturer's reference number (b)(4).

• Brand Name: PAIR OF PIVOT-MOUNTED ELONGATION TUBES
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 17405411
• MDR Text Key: 319877971
• Report Number: 8010652-2023-00065
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100259A0
• Device Catalogue Number: 100259A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other