MAUDE Adverse Event Report: MAQUET GMBH OTESUS OR TABLE COLUMN MOBILE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 116001C0

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

Patient Problem Skin Tears (2516)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and mayfield accessory.As it was stated, at the end of surgery, an unspecified issue occured that led to a 2 cm lateral cut at skin level, which required a suture placement.The investigated issue led to serious injury, therefore, we decided to report the issue.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event or problem field deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 11th july, 2022 getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and mayfield accessory.As it was stated, at the end of surgery, an unspecified issue occured that led to a 2 cm lateral cut at skin level, which required a suture placement.The investigated issue led to serious injury, therefore, we decided to report the issue.Corrected b5 describe event or problem: on 11th july, 2022 getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and mayfield accessory (doro).As it was stated, at the end of surgery, an unspecified issue occured that led to a 2 cm lateral cut at skin level, which required a suture placement.The investigated issue led to serious injury of the patient, therefore, we decided to report the issue.

Event Description

On 11th july, 2022 getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and mayfield accessory (doro).As it was stated, at the end of surgery, an unspecified issue occured that led to a 2 cm lateral cut at skin level, which required a suture placement.The investigated issue led to serious injury of the patient, therefore, we decided to report the issue.

Event Description

On 11th july 2022 getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and pro med instruments accessories (doro).According to initially provided information, at the end of the surgery, a displacement of the device occurred that led to a 2 cm lateral cut at skin level, which required a suture placement.Stitches application is considered as medical intervention to preclude permanent damage to a body structure, thus the decision that described incident led to serious injury and was reported as such.

Manufacturer Narrative

Getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and pro med instruments accessories (doro).According to initially provided information, at the end of the surgery, displacement of a device occurred that led to a 2 cm lateral cut at skin level, which required a suture placement.The investigated issue led to serious injury, therefore, we decided to report the event.At that time, it was unclear which product was directly involved with the reported incident.The affected devices have been evaluated by the getinge service technician.The operating table functions were tested and considered as up to the specification.The doro accessories manufactured by the external company were also evaluated and turned out to be defective, as no malfunction within the getinge operating table was discovered, the device was returned to the usage.The legal manufacturer of the doro accessories (pro med instruments) performed root cause analysis and evaluation of the affected neurosurgical head holder system which allow us to establish that the incident took place due to the failure of 3003-00 doro® skull clamp, which is not distributed by maquet gmbh.Several findings were indicated by pro med ( the damage coating, the helicoil /thread insert coming off due to parts being damaged and worn, too low torque screw pin pressure measurement, rough movement of the skull clamp extension assembly in the skull clamp base, teeth of a starburst out of specification and wearing of parts of the open/lock-mechanism) that were connected to frequently use, reprocessing of the device, improper use, improper or lack of maintenance activities.All of the above could have been a factor leading to the slippage incident, which is likely to have an outcome as described by the customer.Pro med also indicated that a deviation of the torque screw pin pressure measurement is, in their experience, one of the contributory factor to slippages as well.Nevertheless, it could have been avoided by user following the instruction for use, particularly the section describing how to secure the patient¿s head to the skull clamp.With the investigation performed it was concluded that upon the event occurrence, the device was being used for patient¿s treatment, thus was also directly involved with the reported incident.As no actual malfunctions were found it was considered that getinge device was up to the specification.There were no similar complaints found related to this issue investigated herein, therefore it appears to be isolated to this single occurrence, when considering this particular device range, thus the investigated issue is considered an isolated case.We currently do not have any information that would warrant further action towards the getinge device, however as per our complaint handling processes we will continue to monitor the customer experiences with the device for any future information.The correction of b1 adverse event/product problem, b5 describe event or problem and h6 medical device ¿ problem code fields deems required.This is based on the additional information that has been received and the internal evaluation.Previous b1 adverse event/product problem: adverse event & product problem.Corrected b1 adverse event/product problem: adverse event.Previous b5 describe event or problem: on 11th july, 2022 getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and mayfield accessory (doro).As it was stated, at the end of surgery, an unspecified issue occured that led to a 2 cm lateral cut at skin level, which required a suture placement.The investigated issue led to serious injury of the patient, therefore, we decided to report the issue.Corrected b5 describe event or problem: on 11th july 2022 getinge became aware of an issue with one of our tables ¿ 116001c0 - otesus or table column mobile and pro med instruments accessories (doro).According to initially provided information, at the end of the surgery, a displacement of the device occurred that led to a 2 cm lateral cut at skin level, which required a suture placement.Stitches application is considered as medical intervention to preclude permanent damage to a body structure, thus the decision that described incident led to serious injury and was reported as such.Previous h6 medical device ¿ problem code: insufficient information|||3190.Corrected h6 medical device ¿ problem code: use of device problem|||1670.

• Brand Name: OTESUS OR TABLE COLUMN MOBILE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• 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: 15026677
• MDR Text Key: 295957189
• Report Number: 8010652-2022-00011
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 116001C0
• Device Catalogue Number: 116001C0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention