MAUDE Adverse Event Report: GYRUS ACMI, INC ELITE 2 SYSTEM ROTATING CF RESECTOSCOPE OUTER SHEATH, 25FR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number E2ROS-CF25

Device Problem Break (1069)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

The device has returned to olympus for evaluation; however, the evaluation has not yet concluded.The cause of the reported complaint cannot yet be confirmed.A potential factor in the event is inadequate pre-procedure inspection of the device for compatibility with concomitant devices.The e2ros-cf25 instructions for use states, ¿ensure that all components to be used are compatible for use with each other according to these instructions and the instructions for use for the other components to be used.Failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences or injury to the patient.¿ and ¿please note that elite 2 system sheaths and obturators cannot be interchanged with usa elite system sheaths and obturators.¿ a similar warning exists in the instructions for use for the concomitant devices in the elite system.As a preventive measure against system mixup, the elite system components are also color coded purple.The e2ros-cf25 instructions for use also states that during assembly of the devices prior to use, the sheaths must be kept parallel to avoid device damage: ¿if the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may damage the sheath¿s distal tip.If drag or resistance is encountered during assembly or disassembly, stop¿align working element and sheath parallel to one another before proceeding.¿.

Event Description

Olympus was informed that during an unknown procedure, the tip of the device broke off into the patient¿s uterus.The clinician attempted to remove the tip using another unknown device.The broken off tip then fragmented.The clinicians could not locate all the fragments for removal, so the entire uterus was removed.The user facility reported that after internal investigation, it was found that the model e2ros-cf25 of the reported device was not compatible with the other devices used during the procedure.The e2ros-cf25 model belonged to the elite2 system, and the concomitant devices belonged to the elite system.The user facility reported that a model eros-cf25 device would have been the correct device to use.The user facility attributed the cause to a restocking error at their site.The user facility has since quarantined their stock of e2ros-cf25.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results and correct the patient code.The device was returned to olympus for evaluation.The evaluation confirmed the complaint for broken off tip.The device was received with the ceramic tip missing.A small dent was seen on the outer shaft of the sheath.

• Brand Name: ELITE 2 SYSTEM ROTATING CF RESECTOSCOPE OUTER SHEATH, 25FR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8057647
• MDR Text Key: 126903723
• Report Number: 2951238-2018-00698
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E2ROS-CF25
• Device Catalogue Number: E2ROS-CF25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ERIS-CF25 INNER SHEATH; OLYMPUS ERTO-CF25 OR ERVO-CF25 OBTURATOR
• Patient Outcome(s): Required Intervention