MAUDE Adverse Event Report: GYRUS ACMI INC SLIMLINE SEMI-REGID FORCEPS; SEMI-RIGID ALLIGATOR FORCEPS

Model Number GYA-5

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The user facility reported that during a procedure, the jaw at the tip of the forcep broke off and fell into the pt.The jaw was retrieved from the pt.No pt injury was reported.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for eval.If add'l info or if the device is received at a later time this report will be supplemented.

• Brand Name: SLIMLINE SEMI-REGID FORCEPS
• Type of Device: SEMI-RIGID ALLIGATOR FORCEPS
• 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 schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3802398
• MDR Text Key: 16082652
• Report Number: 2951238-2014-00066
• 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: 01/30/2014

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: GYA-5
• Device Catalogue Number: GYA-5
• Device Lot Number: 2165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 02/21/2014
• 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
• Patient Sequence Number: 1