MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR; GRASPER FORCEPS REUSABLE

Model Number	83932936
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is pending the manufacturer device evaluation.Upon receipt of new / additional information, a follow up report will be submitted.
Event or Problem Description
On (b)(6) 2020, rwmic received the medwatch report # 2700490000-2019-8022 from fda.On (b)(6) 2020, rwmic reached out to the initial reporter to receive additional information.It was reported that during a laparoscopic nissen with dr.While the laparoscopic grasper broke while being used on the patient.All the pieces were retrieved from inside the patient.The procedure was finished and the patient was transferred to pacu in stable condition.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information, new information, and changed information.The customer was contacted and in their email response, dated (b)(6) 2020, the device will be not returned to richard wolf mic for investigation.Therefore no further evaluation could be conducted; as a result, a probable root cause could not be determined.Previous complaints from 2017-2020 were reviewed; no trend was identified.The following fields have new or changed information: b5, d10, h1, h2, h3, h6 and h10 device labeling was reviewed for patient code and device codes, see below: - patient code: not applicable, no patient problem was reported.Device code: ifu (ga--s 025) was reviewed, the following cautions, warnings, and checks were outlined in the device instruction for use (ifu): caution! the products have only limited strength excessive force will cause damage, impair the function and therefore end-ager the patient.Due to the small dimensions required, the products have only limited strength.Use these products only to grasp and ablate small, soft tissue portions or organs.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Caution! be careful if products are damaged or incomplete! injuries of the patient, user or 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.Reprocessing: due to the product design and the materials used it is not possible to define a specific limit of the maximum allowable reprocessing cycles.The life cycle of medical products is defined by their function and proper handling.Rwmic considers this mdr closed.A follow up report will be submitted upon receipt of new or additional information.Attachment: [ga-s025 usa_3.0 (11-0209).Pdf].
Event or Problem Description
It was reported by the user facility that during a laparoscopic nissen with dr.While the laparoscopic grasper broke while being used on the patient.All the pieces were retrieved from inside the patient.The procedure was finished and the patient was transferred to pacu in stable condition.

• Brand Name: ERAGON MODULAR
• Common Device Name: GRASPER FORCEPS REUSABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10307619
• Report Number: 1418479-2020-00007
• Device Sequence Number: 19398399
• Product Code: GEI
• UDI-Device Identifier: 04055207015995
• UDI-Public: 04055207015995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020
• Report Date (Section F): 07/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 83932936
• Device Catalogue Number: 8393.293
• Device Lot Number: 1212767
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2020
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 79
• Date Report Sent to FDA: 07/21/2020