MAUDE Adverse Event Report: RICHARD WOLF GMBH MORCELLATOR CUTTING TUBE 12MM

Model Number 8307012

Device Problems Corroded (1131); Device Contaminated During Manufacture or Shipping (2969); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

A richard wolf (b)(6) dist reported a contamination of a morcellator cutting tube 12mm.The dealer in (b)(4) noticed at the incoming inspection a contamination.

Manufacturer Narrative

A full investigation is currently in process as the actual device was returned to the richard wolf (b)(6).Richard wolf considers this matter opened.When additional info is received, we will provide fda with follow-up.

Manufacturer Narrative

Lot, consisted of 10 pieces, was received from supplier and purchased by customer on 11jun2014.Visual examination found both cutting tubes contained residue in the interior, which promoted the corrosion of the device.Specifically, corrosion was found in the transition area from the pipe to the driver and the area of the coded pins.Supplier has eliminated the groove in the transition area in order to greatly reduce residue accumulation.In addition, supplier has improved the cutting tubes near the insertion and tightened tolerances.Change implemented under supplier capa (b)(4).Since the market launch on 13jun2008 no similar complaints of cutting tube corrosion have been received.Instructions for use (ifu), ga-a245, contained sufficient instructions.In the risk assessment, e5-1, potential risks of the cutting tube were taken into account and had an acceptable risk rating.Richard wolf (b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of (b)(4).

Event Description

Follow up #1.

• Brand Name: MORCELLATOR CUTTING TUBE 12MM
• Type of Device: MORCELLATOR CUTTING TUBE 12MM
• Manufacturer (Section D): RICHARD WOLF GMBH; knittlingen 75438 ; GM 75438
• Manufacturer Contact: dawn clark ; pforzheimer str. 32; knittlingen 75438 ; GM 75438 ; 8479558016
• MDR Report Key: 4129427
• MDR Text Key: 21495281
• Report Number: 9611102-2014-00008
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,company representative,dis
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8307012
• Device Catalogue Number: 8307012
• Device Lot Number: 6550C1404R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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