MAUDE Adverse Event Report: GYRUS ACMI INC. USA ELITE RIGID OPTICAL GRASPING FORCEPS

Model Number E8215

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

The user facility reported that during a procedure, while the physician was using the grasping forceps the tip broke off and fell inside the patient.The physician used a second forceps and the tip also broke off.The broken pieces were retrieved from the patient, the procedure was successfully completed using a third grasping forceps.No patient injury was reported.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined.If additional information is received at a later time this report will be supplemented.

• Brand Name: USA ELITE RIGID OPTICAL GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4089355002
• MDR Report Key: 4173535
• MDR Text Key: 19800753
• Report Number: 2951238-2014-00448
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2014

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: E8215
• Device Catalogue Number: E8215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Other