MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT

Model Number 8792.636

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Sales rep from richard wolf medical instrument corporation (rwmic) was visiting facility and was told about an incident that occurred during a procedure.The grasping claws on device broke and half of claws fell into pt.The piece was unable to be retrieved.In order to complete the procedure, a backup device was used.No consequences to pt or staff has been reported.

Manufacturer Narrative

An investigation has not been completed as the actual device was not returned to rwmic as of (b)(4) 2014.Device is currently in transit to rwmic.Richard wolf considers this matter opened.Device is currently in transit to rwmic for investigation.Once the device is received and add'l info is available, a f/u report will be provided.

Event Description

This is a follow up report to change status of this report from open to closed, no new information added.If any additional information is received it will be forwarded to manufacture.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; GM
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: 353 corporate woods pkwy.; vernon hills, IL 60061
• MDR Report Key: 4136407
• MDR Text Key: 21448043
• Report Number: 1418479-2014-00043
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown,unknown
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2014,08/22/2014

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: 8792.636
• Device Catalogue Number: 8792.636
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Distributor Facility Aware Date: 08/22/2014
• Device Age: 9 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/19/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1