MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; INTERNAL SHEATH RESECTOSCOPE 26FR

Model Number	86553841
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic received the device which was visually evaluated and observed to have a broken ceramic tip.The investigation determined, possibly cracked during reprocessing, or handling.The probable root cause was determined to be user handling.The tip was replaced, cleaned, and tested.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 warnings, cautions, and checks were found: use: caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore en-danger 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.Checks: 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.From the reprocessing guide: important after use, reprocess the products without any major delay to guarantee efficient and gentle reprocessing.Checks and maintenance caution! be careful if products are damaged or incomplete! injuries to 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.Rwmic considers this case closed.A follow up report will be submitted upon receipt of new or additional information.
Event or Problem Description
It was reported to richard wolf medical instruments that on (b)(6) 2016, a tip broke off in a patient, they were able to retrieve with no injury to the patient.Additional information: (b)(6) called a.G.To go over event, pieces fell off in one large piece.Grasper was used to retrieve pieces.No backup device, but still usable to complete case (near end of case).No injury to patient, no post procedure complications.Minimal time to retrieve.Minimal risk.((b)(6) 2016).Will the device be returned? yes.Was the device being used on a patient when the reported issue occurred? yes.Was there any injury or illness to patient due to reported issue? no.Was there any injury or illness to any other personnel due to reported issue? no.Did the issue cause a delay in the procedure being performed? no.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.

• Brand Name: E-LINE
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 26FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10599458
• Report Number: 1418479-2016-00022
• Device Sequence Number: 3273123
• Product Code: FDC
• UDI-Device Identifier: 04055207028094
• UDI-Public: 04055207028094
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 86553841
• Device Catalogue Number: 8655.3841
• Device Lot Number: 1283337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1