MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. ERAGON; FORCEPS

Catalog Number 83933226

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

While the surgeon was using a debakey grasper the jaws broke inside the patient.Two pieces including one of the jaws itself and a small set screw that holds the jaws together.An x-ray was conducted and nothing that corresponded to a screw was noted in the surgical field.
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manufacturer response for debakey grasper with locking handle, eragon debakey graspers with locking handle (per site reporter).
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the manufacturer demanded that the unit be sterilized before it was shipped to them.They said they would conduct an investigation into the products malfunction.

• Brand Name: ERAGON
• Type of Device: FORCEPS
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061
• MDR Report Key: 4894453
• MDR Text Key: 6537859
• Report Number: 4894453
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 83933226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2015
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 123