MAUDE Adverse Event Report: MAQUET GMBH PAIR OF LEG PLATES, 4-PART; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 113373BC

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Skin Tears (2516)

Event Type  malfunction  

Event Description

On (b)(6) 2023, getinge became aware of an incident with one of our accessories ¿ 113373bc - pair of leg plates, 4-part.As it was stated, user sustained cut while operating the quick release of the leg plate.According to the provided information, the cut was dressed and no medical intervention was required.We decided to report the issue based on the potential for serious injury if the situation, namely the user's body cut during use of the leg plate, was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an incident with one of our accessories ¿ 113373bc - pair of leg plates, 4-part used with 116010b0 ¿ universal table top, sfc, eu.As it was stated, user sustained cut while operating the quick release of the leg plate.The staff pinched their fingers while using the closure.According to the provided information, the cut was dressed and no medical intervention was required.We decided to report the issue based on the potential for serious injury if the situation, namely the user's body cut during use of the leg plate, was to reoccur.Unfortunately, despite many attempts, the affected getinge device has not been evaluated by the company¿s service technician as appointments were cancelled by the customer.The technician has pointed out that the use of the leg plates with catalog number 113373bc is difficult and that getting fingers caught during locking is probable.The subject matter expert at manufacturing site was contacted to analyze the concerns reported by the technician and to establish the root cause of this issue.The sme assessed that the design implemented in the affected leg plates was developed with security against unwanted release and he did not identify any pinching risk.In the instruction for use (ifu 1333.73 en 07, page 11), the user is informed about danged resulting from improper handling.The user is also warned (ifu 1333.73 en 07, page 11), that when adjusting, moving or storing or table/ table top, the staff, the patient and the accessories are exposed to pinching and shearing hazards, particularly in the area around the joints at the head rest, back and leg plates.The user shall always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects.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, it was directly involved with the reported incident.Despite many attempts, the device was not inspected by the getinge service technician and it was not possible to establish if the device was working up to its specification or not.Based on available information the sme established that the issue was most likely caused by the user error.The issue investigated herein is a single and isolated case.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 b1 adverse event / product problem and h6 health effect ¿ clinical code fields deems required.This is based on the internal evaluation.Previous b1 adverse event / product problem: product problem.Corrected b1 adverse event / product problem: adverse event & product problem.Previous h6 health effect ¿ clinical code: skin and subcutaneous tissue|skin tears||2516; corrected h6 health effect ¿ clinical code: injury|laceration(s)||1946.

Event Description

On 17th january 2023, getinge became aware of an incident with one of our accessories ¿ 113373bc - pair of leg plates, 4-part used with 116010b0 ¿ universal table top, sfc, eu.As it was stated, user sustained cut while operating the quick release of the leg plate.The staff pinched their fingers while using the closure.According to the provided information, the cut was dressed and no medical intervention was required.We decided to report the issue based on the potential for serious injury if the situation, namely the user's body cut during use of the leg plate, was to reoccur.

• Brand Name: PAIR OF LEG PLATES, 4-PART
• 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: 16251954
• MDR Text Key: 308542605
• Report Number: 8010652-2023-00006
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 113373BC
• Device Catalogue Number: 113373BC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 116010B0 - UNIVERSAL TABLE TOP
• Patient Outcome(s): Other