ESCHMANN LEG HOLDER

MDR report key: 6941616 · Received October 11, 2017

Report

Report Number: 1221538-2017-00003
Event Type: Malfunction
Date Received: October 11, 2017
Date of Event: May 1, 2017
Report Date: June 30, 2017
Manufacturer: ALLEN MEDICAL SYSTEMS, INC.
Product Code: FWZ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AWAITING RETURN OF THE DEVICE FOR EVALUATION. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION.

Additional Manufacturer Narrative · 1

THE DEVICE WAS RECEIVED AT THE MANUFACTURER, (B)(4). A ROOT CAUSE INVESTIGATION COULD NOT BE COMPLETED AS THE DEVICE HAD ALREADY BEEN REPAIRED BY (B)(4). (B)(4) WAS UNAWARE THE DEVICE NEEDED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. IN ITS CURRENT CONDITION, THE DEVICE FUNCTIONS PROPERLY AND PASSES ALL LOAD TESTS, SO WE CAN NO LONGER CONFIRM ROOT CAUSE NOR FAILURE.

Description of Event or Problem · 1

LEG HOLDER ATTACHED TO A MAQUET TABLE FOR A LAPAROSCOPIC SMALL BOWEL RESECTION LITHOTOMY POSITION. NEAR END OF PROCEDURE 2HRS, RIGHT LEG HOLDER GAVE WAY, WAS CAUGHT BY STAFF AROUND LEVEL OF TABLE. PATIENT TOLD OF INCIDENT AFTERWARDS AND OFFERED AN X-RAY IF NEEDED, THEATRE STAFF SAY NO COMPLAINT OF PAIN REPORTED, NO REPORT OF INJURY AND NO DATA OF INJURY RECEIVED.

Description of Event or Problem · 1

DPLH ATTACHED TO A MAQUET TABLE FOR A LAPAROSCOPIC SMALL BOWEL RESECTION LITHOTOMY POSITION. NEAR END OF PROCEDURE 2HRS, RIGHT DPLH GAVE WAY, WAS CAUGHT BY STAFF AROUND LEVEL OF TABLE. PATIENT TOLD OF INCIDENT AFTERWARDS AND OFFERED AN XRAY IF NEEDED, THEATRE STAFF SAY NO COMPLAINT OF PAIN REPORTED, NO REPORT OF INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
720814	ESCHMANN LEG HOLDER	STIRRUP	FWZ	ALLEN MEDICAL SYSTEMS, INC.	F-LHESCH-A2

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Other