MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. FORCEPS, TENACULUM

Model Number 8370.26

Device Problems Device Inoperable (1663); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2012

Event Type  malfunction  

Event Description

Device broke, no injury or delay in procedure was reported.Two devices involved, they consist of the following: 1) tenaculum (8370.26), report: 1418479-2014-00020; 2) tenaculum (8370.26), report: 1418479-2014-00021.

Manufacturer Narrative

Handle is manufactured by richard wolf.It is then sent to endoplus where they manufacture and attach the insulated sheath and forceps.Completed device is then returned to richard wolf for distribution.An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2013.Device was then sent to (b)(4) for additional investigation.Investigation revealed incorrect handle had been assembled on forceps.Manufacture date: nov 2011.Richard wolf considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.

• Brand Name: FORCEPS, TENACULUM
• Type of Device: FORCEPS
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; vernon hills IL
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3898958
• MDR Text Key: 15122737
• Report Number: 1418479-2014-00020
• Device Sequence Number: 1
• Product Code: HCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8370.26
• Device Catalogue Number: 8370.26
• Device Lot Number: 1N11
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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