MAUDE Adverse Event Report: HOLGER ULLRICH GOEPEL KNEE CRUTCH; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100165A0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Unspecified Tissue Injury (4559)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

At time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.(b)(6).

Event Description

The following was reported to us.A surgery was performed to treat a patients endomitriosis.During the surgery the product 100165a0 "goepel knee crutch" was used.The leg holder cover 1000.28a0 was used with this product.The patient had a compartment syndrome in the right leg, which was treated.Manufacturer reference#: (b)(4).

Manufacturer Narrative

In the affected clinic several goepel knee crutches 100165a0 are used.The clinic did not tell us, which of these knee crutches was in use, when the incident occurred.Some time has passed between the incident ((b)(6)2019) and the date on which we were informed about it (aware date, december 2020).We have not received a complaint from the clinic concerning the affected knee crutch except the notification about the adverse event.Therefore we assume that the product was not damaged.According to the instructions for use (ifu), the user is obliged to check the product prior to use and not to use a defective product.The user is warned concerning the risks related to using a defective product as follows: "warning! risk of injury! faulty or defective products may result in injuries.Before use, check the proper working order and fully functional state of the product.Stop using faulty or defective products and inform the getinge representative." the complaints database was reviewed concerning similar complaints for the affected model.No similar complaints or comparable incidents were registered.Further information concerning the patient or the conducted surgery were requested from the clinic.The clinic stated that further information concerning this case will not be provided in a timely manner.A compartment syndrome can be caused by various influences (long duration of the surgery, positioning of the patient, especially in lithotomy position in trendelenburg position, high bmi, intraoperative compression of large blood vessels,.).We suspect that a combination of some of these unfavorable factors has been present in this case and caused the described injury.The surgery was described as "extended endometriosis treatment".Due to this description, we assume that the duration of the surgery was extended.The described surgery is a gynecologic intervention.The trendelenburg position is common for this kind of intervention.We have requested the exact duration from the clinic, but the customer has stated that this request will not be answered in a timely manner.An extended duration of the surgery in a lithotomy position and trend position are high risk factors for a compartment syndrome.In the ifu the user is warned concerning the risks related to patient positioning as follows: "warning! risk of injury! improper patient positioning may cause health damage (e.G.Decubitus).Position the patient correctly and keep under constant observation." concerning code 4650 for health effects - health impact: the clinic has told us, that no further information concerning the injury or the treatment of this injury will be provided in a timely manner.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

It was stated that an extended surgery was performed to treate a patients endomitriosis.Manufacturer reference#: (b)(4).

• Brand Name: GOEPEL KNEE CRUTCH
• 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: 10976589
• MDR Text Key: 220463216
• Report Number: 3013876692-2020-00069
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 100165A0
• Device Catalogue Number: 100165A0
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2021
• Distributor Facility Aware Date: 06/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEG HOLDER COVER 100028A0.; LEG HOLDER COVER 100028A0
• Patient Outcome(s): Other