MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; SHEATH RESECTOSCOPE 9FR REUSABLE

Model Number 86880145

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Rw (b)(4) is in the process of investigating this complaint.A follow up report will be submitted with the investigation results.(b)(4).

Event Description

On (b)(6) 2021 richard wolf (b)(4) was informed by the hospital about an adverse event.Richard wolf (b)(4) complaint reference (b)(4).During the application, the ceramic insulating sleeve broke off in the patient.The surgeon was able to recover a larger fragment as well as a small triangular-shaped fragment from the patient.This extended the operating time by about 15 minutes.Another operation is planned.

Manufacturer Narrative

Richard wolf mic is submitting this report on behalf of richard wolf gmbh.Investigation: shaft for resectoscope 9ch has the following product damage: insulating insert 15 003.221 made of zirconium oxide (ceramic) detached from shaft and broken.Insulating insert (ceramic sleeve) and broken piece were added to the reclaimed product.Adhesive residues visible at the distal end of the shaft and on the outer circumference of the detached insulating insert.Note: the connection between the insulating insert (ceramic) and the shaft tube (1.4301) is a proven adhesive connection.Otherwise, no other damage to the product is apparent.The product shows a mint condition.The laser inscription on the product is still clearly legible the surfaces of the product exhibit as-new condition the shaft tube shows no external load damage (pressure points, bending).No external thermal discoloration or damage to the shaft tube and insulating insert due to electrical influences (use of hf current) can be detected.The period 01.01.2018 to 26.03.2021 was subjected to a closer examination of the complaint database.During this period 266 shaft for resectoscope 9ch, type number 8688.0145 were sold, there were no similar cases in the period under consideration.There are no similar occurrences.A product, manufacturing or batch defect is therefore not identifiable.In our risk analysis d3 rev 04 (reusable shafts and tubes), manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks due to an unusable product were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed with an acceptable risk.A detailed risk analysis was carried out during the development of the product.In the risk assessment d3 rev 04, the extent of damage and with the assumed probability of occurrence was considered and assessed with an acceptable risk.According to risk assessment d3 rev 04: hazard (2): mechanical energy, functions/components (1): distal end, causes (3): handling-related.Damage (3): reversible damage, additional intervention if necessary.Instructions for use ga--d 363 / en / index: 2018--11 v3.0 / pk18-9338 contains the following applicable warnings for these faults: 7 application.Caution! limited stability of the products! excessive application of force will result in damage, impair the function and thus endanger the patient.Check products for damage, loose parts and completeness immediately before and after use.Loose parts and completeness.No missing parts may remain in the patient.Do not use products that are damaged, incomplete or have loose parts use them again.7.4 inserting auxiliary instruments: when using the attachment with 1 insertion stopcock (4b), flexible auxiliary instruments can be inserted according to the size of the passage [see marking on the resectoscope shaft (2)] and with a useful length of at least 230 mm.Caution! risk of injury when inserting the auxiliary instruments if they are not in the surgeon's field of vision! unintentional tissue damage is possible.Insert auxiliary instruments only under visual control.Perform manipulations only if the auxiliary instruments are completely in the surgeon's field of view.Caution! injuries and damage to the resectoscope when inserting and retracting forceps and scissors with open jaws! unintentional tissue damage, damage to the distal end of the resectoscope and loss of particles from the jaws are possible.Only insert and retract forceps and scissors with closed jaws and under visual control.8 control: caution! take care with damaged and incomplete products! injuries to the patient, user and third parties are possible.Perform checks before and after each use.Do not use products that are damaged, incomplete or have loose parts.Use them any longer.Send damaged products with the loose parts for repair.Do not attempt to carry out repairs yourself.8.1 visual inspection: check instruments and accessories for: damage, sharp edges, loose or missing parts, rough surfaces.Labels and markings required for safe and proper use must be legible.Missing, illegible inscriptions and markings that lead to errors in handling and handling and reprocessing must be restored.The product was probably only subjected to mechanical stress during proper use.Thermal influences due to the use of hf current are not evident.Based on the damage pattern, it can primarily be assumed that the adhesive connections between the shaft and the insulating insert have failed.The break in the ceramic of the insulating insert could have been caused when the component was detached from the shaft tube.Pre-damage of the insulating sleeve may also have occurred as a result of external mechanical influences during preparation of the product.If pre-damage of the ceramic is assumed, a causal stress crack on the ceramic, which is difficult to see from the outside, must generally be assumed, which could ultimately lead to breakage and detachment of the insulating insert from the socket.Richard wolf gmbh(rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation(rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.

Event Description

Results of the device evaluation revealed: the customer reports damage to the product that occurred during use.The damage involves the detachment and breakage of the insulating insert (ceramic sleeve) at the distal end of the shaft of a 9ch resectoscope type 8688.0145.The insulating insert completely detached from the shaft, as well as a smaller fragment, had to be recovered from the patient's urinary bladder by the user.The insulating insert, as well as a smaller fragment, could be successfully recovered from the patient's urinary bladder with the aid of forceps.Grit or smaller concretions were drained from the bladder via an 8ch bladder balloon catheter after discontinuation of the procedure.The product is a shaft for resectoscope 9ch, type number 8688.0145 from lot 1286350 - recorded on 02/03/2021 with claim number 700015717.The product was shipped to the customer on 10/21/2015.Please see manufacturers narrative for additional information.

• Brand Name: E-LINE
• Type of Device: SHEATH RESECTOSCOPE 9FR REUSABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11385349
• MDR Text Key: 241368611
• Report Number: 9611102-2021-00009
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207028575
• UDI-Public: 04055207028575
• Combination Product (y/n): N
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 86880145
• Device Catalogue Number: 8688.0145
• Device Lot Number: 1286350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other