MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR ATRAUMAT.GRASP.FORCEPS; ENDOSCOPIC GRASPING FORCEPS

Model Number 83932297

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The forceps were not returned by the customer for evaluation by rw (b)(4).The inner part of the forceps was evaluated via photographic samples and the manufacturing documents.The retaining eyelet for the moveable jaw was found to be broken out.The conclusion of the investigation is that a handling error is indicated.In conclusion, from the available evidence, the inner part of the forceps was found to be mechanically overloaded.This resulted in a fracture of the joint eyelet.The inner part of the forceps is attached to the shaft tube with a bayonet lock.This prevented a loss of parts or loosening of the joint area.In the instructions for use the user is informed of the limited mechanical strength of the grasping forceps.The user is also instructed to perform visibility and functional checks before and after use serve the user for early detection of possible damage.8 inspection caution! be careful if products are damaged or incomplete! injuries of the patient, user and others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.8.1 visual check the instruments and accessories for the following: damage, surface changes (e.G.Corrosion), sharp edges not suitable for the application, loose or missing parts, rough surfaces.Any inscriptions or identification necessary for the safe intended use must be legible.To prevent wrong handling or reprocessing, any illegible lettering, labeling or identification must be reinstated.Check the insulation of the hf cable for damage.Replace the hf cable if the insulation is damaged.Check the insulation of the sheath tube for mechanical damage and dielectric breakdown (punctures).Do not use the forceps and scissors if the insulation is damaged.Caution! damaged surface in the joint area of the forceps! the joint pin may loosen.Check for surface changes, such as fissures, at the joint pin.A closer examination of the complaint database was carried out from 01/01/2016 to 10/25/2019.During this period 340 eragon modular atraumat.Grasp.Forceps (83932297) were sold, and during the period under review there were no further complaints.A product or batch problem is therefore not recognizable.This is an isolated case.Potential hazards were taken into account in risk assessment b1-2 rev.05 with the corresponding severity of harm and probability of occurrence and assessed with an acceptable risk.This rating is still valid considering the current case.Since the user had to abort the operation, this is a reportable event.The detected defect of the inner part of the pliers does not describe a general product problem with non-conformity, negative trend or hitherto unknown hazards.The complaint relates to a handling error.A systematic problem is not recognizable.Warnings and checks are described in the instructions for use and are considered to be sufficient.No further investigation or action by the manufacturer is warranted for this case, other than the continued monitoring of complaints so that any possible trends can be identified.Rw gmbh considers this case closed.

Event Description

On october 25, 2019, richard wolf (b)(4) received the following information: during the first use, there was a breakage of the active part.The error occured during a surgical procedure without causing any harm to the patient, but the surgery was canceled.

• Brand Name: ERAGON MODULAR ATRAUMAT.GRASP.FORCEPS
• Type of Device: ENDOSCOPIC GRASPING FORCEPS
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10131018
• MDR Text Key: 240978478
• Report Number: 9611102-2019-00037
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207061770
• UDI-Public: 04055207061770
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K93527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

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: 83932297
• Device Catalogue Number: 83932297
• Device Lot Number: 1411363
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other