MAUDE Adverse Event Report: RICHARD WOLF GMBH MODULINE; ATRAUMATIC GRASPER FORCEPS MONOPOLAR

Model Number 8393.1814

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this case open.The manufacture and user facility will be contacted to collect missing information.A follow up report will be submitted upon receipt of new or additional information.

Event Description

On january 21st 2019, the user facility reported the following to richard wolf medical instruments corporation (rwmic): while being used on a procedure, a part of the forceps fell in the patient.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.

Manufacturer Narrative

Follow up report # 1 is to provide fda with new and changed information.New / changed information : b3, d4, d10, f7, f11, f13, g4, g7, h2, h10 richard wolf medical instruments corporation (rwmic) considers this case open.Upon device evaluation or any additional information a follow up report will be submitted to fda.

Event Description

Follow up report to provide new and/or changed information.

Manufacturer Narrative

Device labeling was reviewed for patient and device codes: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed the following cautions and checks were found: caution! excessive force can lead to breakage of or damage to the products.Due to the small dimensions required, the products have only limited strength.Use these instruments only to grasp and ablate small portions of tissue of the kinds defined in chapter 1.Immediately after use check the instruments for damage and for parts which may have broken off.Ensure that these parts do not remain in the patient.Caution! the products have only limited strength! exerting excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Ensure that no missing instrument parts remain in the patient.Do not use products which are damaged, incomplete or have loose parts.Check instruments and accessories for damage, sharp edges and rough surfaces.Check jaw inserts for defective cutting edges and corroded parts and replace, if necessary.Check insulation of hf cable and sheaths and replace, if necessary.Caution! check for surface changes (e.G.Hairline cracks) in the area of the hinge pin the pin may loosen if the surface is damaged.Additional attempts were made to collect additional/missing information from the user facility, but no additional information could be provided.Rwmic considers this case closed.Should additional information become available a follow up report will be submitted.

Event Description

The user facility returned the device to richard wolf medical instruments corporation (rwmic) on june 26, 2019 and the device evaluation was completed on july 17, 2019.The device was visually and functionally evaluated using a magnifier.The instrument was found to have been repaired by a third party; as a result, the reported condition could not be verified.A probable root cause could not be determined as the instrument was repaired by a third party.

• Brand Name: MODULINE
• Type of Device: ATRAUMATIC GRASPER FORCEPS MONOPOLAR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8353592
• MDR Text Key: 136866060
• Report Number: 1418479-2019-00003
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04055207062098
• UDI-Public: 04055207062098
• Combination Product (y/n): N
• PMA/PMN Number: K935270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019,01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8393.1814
• Device Catalogue Number: 8393.1814
• Device Lot Number: 112N11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Distributor Facility Aware Date: 01/21/2019
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention