MAUDE Adverse Event Report: HOLGER ULLRICH EXTENSION DEVICE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 141901B0

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

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

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the investigation is still ongoing.As soon as the investigation is finished, the report will be updated, and a follow-up/final report will be provided to the fda.Due to the limited amount of allowed characters for the fields, the complete information could not be entered.It is provided below: (b)(6).

Event Description

The following was reported.The extension device (b)(4) was used.The patient was anesthesized.A part of the product dropped, and this resulted in the patient moving on the table.The patient could be hold by the medical team.The surgery was delayed, or postponed.No injury of the patient occurred.A not further specified imaging test was performed.Manufacturer reference# (b)(4).

Manufacturer Narrative

A getinge-maquet service technician has visited the clinic and investigated the affected product (141901b0) and the table it was connected to.The malfunction described by the user could not be reproduced.The product is mounted to the or table via two adapters.The adapters are mounted to the table and other parts of the traction device are afterwards mounted to the adapters.Further inquires with the clinic resulted that one of the two adapters came off, when the incident occurred.Since the malfunction could not be reproduced and no defects related to it were found, we assume that one of the adpaters was not mounted properly or released by mistake.In the instructions for use (ifu) the mounting of the adapter pair is described and the user is told to check their proper fit and ensure they cannot be moved afterwards.In the ifu the user is warned concerning the risks related to loose or loosened securing elements: "risk of injury! products / accessories not attached properly may loosen and cause injuries.Ensure that products / accessories are mounted correctly and that the securing elements (handle screws, catches, levers, etc.) are closed and firmly tightened, also ensure that moving parts are correctly secured".Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The product is mounted to the or table via two adapters.The adapters are mounted to the table and the extension device is afterwards mounted to the adapters.Further inquires with the clinic resulted that one of the two adapters came off, when the product was used.Manufacturer reference (b)(4).

• Brand Name: EXTENSION DEVICE
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 10534594
• MDR Text Key: 206965582
• Report Number: 8010652-2020-00018
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 141901B0
• Device Catalogue Number: 141901B0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 60