MAUDE Adverse Event Report: GYRUS ACMI INC. WEIL BLAKESLEY THRU CUT FORCEPS 4.8MM

Model Number 230730

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the user's experience could not be conclusively determined at this time.If device is returned or additional information becomes available at a later time this report will be supplemented.

Event Description

Olympus was informed that during an unspecified procedure, the bottom part of the device jaw broke inside the patient's nasal cavity.The physicians were unable to locate the broken piece.An xray on the patient's head was performed to locate the broken piece, but was not located.A full body xray was done and the broken piece was located in the patient's stomach.An esophagogastroduodenoscopy (upper endoscopy) procedure was performed by the physicians but they were unable to retrieve the broken piece.The physicians have decided to let the broken piece pass.It is unknown at this time if patient sustained any injuries.No additional information was provided.

• Brand Name: WEIL BLAKESLEY THRU CUT FORCEPS 4.8MM
• Type of Device: WEIL BLAKESLEY THRU CUT FORCEPS 4.8MM
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5095879
• MDR Text Key: 26482659
• Report Number: 2951238-2015-00453
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 230730
• Device Catalogue Number: 230730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention