MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/E-LINE; CUTTING ELECTRODE BIPO 22FR

Model Number 4622.1333

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report for richard wolf (b)(4).Rw (b)(4) considers this mdr/complaint open.Rw (b)(4) will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

The user has reported to rw (b)(4) "that the primary packaging of the cutting electrode is tearing." it is suspected that this poses a risk of contamination during transfer to the "sterile nurse".The described electrodes/packaging could not yet be examined.

Event Description

See manufacturers narrative for results of the investigation.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new information and changed information.Changed information: the following fields have changed information: h3 the results of the device investigation as reported to rw mic by rw gmbh: "the packaging provided by the customer was forwarded to the responsible service provider for packaging of medical devices for detailed examination.The review of the manufacturing documents did not reveal any anomalies.Regarding the manufacturing order, there were no changes to the packaging process or the materials.Sealing seams of the complained packagings of the outer sbs were measured within the scope of the machine release according to p.02.178.The measurement results of 4.8n/15mm-7.0n/15mm were within the specification (limit value 1.5n/15mm-15n/15mm).Furthermore, peelability tests are carried out as part of the machine approval process.In this process, the packaging is checked for proper opening without tearing of the packaging materials.The investigation of the complained products showed that this complaint can be assessed as uncritical, since neither the sterility nor the product itself is negatively affected by tearing of the outer sbs when opening the packaging.Furthermore, the root cause analysis showed that at the point where the film tore while opening the packaging the seal seam is predominantly double-sealed.It is therefore assumed that the packagings are torn at this point due to the way they are handled when opened.Improper handling of the sterile packaging can favour the defect pattern.With the latest revision of the standard din en iso 11607:2020, this point is addressed in section 7 "assessment of suitability for use for aseptic provision".The error pattern could not be reproduced as all complained packagings had already been opened and no more bags of this batch were in stock.Since there were no changes in the packaging process or materials, the machine release was in order and there are no known anomalies with this type of packaging, the complaint was rejected by the service provider for packaging of medical devices and closed without further action.The complained electrodes / packaging are part of an order with a volume of 1914 electrodes.Richard wolf gmbh is not aware of any other similar complaints for the type 46221333 in the period 01.01.2011 to 14.10.2021.Richard wolf gmbh agrees with the assessment of the service provider for packaging of medical devices that the accumulation of damage at the hospital is not due to a material or processing defect.Richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda." richard wolf medical instruments corporation (rwmic) is submitting report on behalf of rwgmbh.

• Brand Name: SHARK/E-LINE
• Type of Device: CUTTING ELECTRODE BIPO 22FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12025193
• MDR Text Key: 275957485
• Report Number: 9611102-2021-00025
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048870
• UDI-Public: 04055207048870
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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 Model Number: 4622.1333
• Device Catalogue Number: 4622.1333
• Device Lot Number: 1459096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• 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