MAUDE Adverse Event Report: GYRUS ACMI INC. CUTTING LOOP

Model Number MLE-24-012

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/09/2014

Event Type  Injury  

Event Description

The user facility reported that during a hysteroscopy procedure a piece of the device broke off inside the pt.The pt cavity and tissue was searched.However, nothing was found.The procedure was completed using the same device no pt injury was reported.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for eval.If add'l info is received at a later time this report will be supplemented.

• Brand Name: CUTTING LOOP
• Type of Device: LOOP
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike rd; southborough MA 01772 210
• Manufacturer (Section G): GYRUS ACMI INC.; 136 turnpike rd; southborough MA 01772 210
• Manufacturer Contact: noemi schamback ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3839287
• MDR Text Key: 4613564
• Report Number: 2951238-2014-00208
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLE-24-012
• Device Catalogue Number: MLE-24-012
• Device Lot Number: 111153GB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other