MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/E-LINE; CUTTING ELECTRODE BIPO 24FR 12/30°

Model Number	4622.1333
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf received a medwatch report from the fda.The report stated: "wolf electrode used for hysteroscopy, myomectomy pricedure: metal loop broke off during procedure but was found outside of the patient, intact." the original intended procedure: operative hysteroscopy, myomectomy, d&c what problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working).Additional information received through direct contact with the user facility: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? no.Did the delay put the patient at risk? n/a.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.
Additional Manufacturer Narrative
Rwmic considers this mdr open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with new and corrected information about this mdr.The results of the due diligence for patient informations: rwmic have contacted the user facility on three (3) occasions requesting for patient informations that were not provided during the initial report submission.A representative from the user facility replied that requested informations are unknown and confirmed that no further information can be provided.(email, aug 9, 2022) device return status: device not being returned as it has been discarded.Rwmic has issued a customer service return authorization no.(b)(4) on 04-apr-2022 for the return of the device.However, information received on 7/27/2022 from a rwmic sales representative stating "the electrode was thrown out." in lieu of the device not being returned, rwmic issued a request to richard wolf gmbh (manufacturer) for a device product history evaluation to be performed.Form 5253 (00), date: 07/28/2022.The results of the device product history evaluation: form 5253 (00) according to rwgmbh investigation report product history evaluation, the reported cutting electrode 4622.1333 with the batch 1445943 was produced with a total number of (b)(4) pack on 03/24/2020.All (b)(4) packs were delivered to rwmic on 07/02/2020.1 pack contains (b)(4) pieces of cutting electrodes.The production order was reviewed, 2 electrodes were sorted out during the inspection and 1 electrode was booked as a partial delivery to another warehouse.Rwmic reached out to rwgmbh to clarify the reason why the 2 electrodes were sorted out during the inspection phase.However, rwgmbh replied that information's are not available.(email, 8/15/22) the complaints database reveals for 'loop breakage during procedure' with product #4622.1333 the following previous complaints in the period between 01/01/2019 - 03/28/2022 (date complaint received): 21-00236 / 700016518 - loop became dislodged; device not returned to gmbh.21-00237 / 700016519 - loop broke off; device not returned to gmbh.22-00108 / 700017975 - loop broke off during surgery; pending investigations.In addition, rwgmbh performed risk assessment bb2-3 and considered the possible risks due to failure with the corresponding extent of damage and the probability of occurrence were assessed as an acceptable risk.In the associated ifu, ga-d342 / en-us / 2020-10 v9.0 / pk20-0319, the user is informed about the following safety notice: section 6 - use caution! the products have only limited strength! excessive force will cause damage, impairs the function and therefore endangers the patient.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.Section 7 - checks.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.Section 7.1.4 - electrodes.Important! for sterile products: sterility is only guaranteed for undamaged and unopened packaging.'do not use the product if the sterile packaging is damaged or the use-by date is exceeded.The user did not report any clinical impact on the patient.Only, device failure as device stopped working.Richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit a follow up report when new information becomes available.
Event or Problem Description
Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device product history evaluation, due diligence inquiry for patient information, as well as new and corrected informations.Rwmic mdr awareness date: 28-mar-2022.

• Brand Name: SHARK/E-LINE
• Common Device Name: CUTTING ELECTRODE BIPO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 14137996
• Report Number: 1418479-2022-00011
• Device Sequence Number: 6231366
• Product Code: FAS
• UDI-Device Identifier: 04055207048870
• UDI-Public: 04055207048870
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022
• Report Date (Section F): 08/15/2022

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 Expiration Date: 02/25/2025
• Device Model Number: 4622.1333
• Device Catalogue Number: 4622.1333
• Device Lot Number: 1445943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 08/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/15/2022