MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE URETERORENOSKOP 12° 8/9,8CH NL 430MMH 1,6MM STANZE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	8703.534
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1x 8703534 ureterorenoscope 12¿ 8/9,8ch nl 430mm with the serial number (b)(4) from batch 1420610 was examined by richard wolf.During the visual examination it was found that the cladding tube is strongly bent, crushed and torn approx.10 cm from the distal end.The conclusion of the investigation is that this damage could only be caused mechanically.The cause of the defect was classified as mechanical overload.The instrument must have been bent against a hard edge.How this could happen on the patient during the intended use of the product is not comprehensible.In addition, no damage or injury to the patient was reported.The ureterorenocope was manufactured with production order 1420610.The production order consists of a total of (b)(4) pieces.The examination of the production documents shows no deviations or anomalies.The operating instructions ga-d 352 / en / 2018-12 v6.0 / pk18-9377 contain the following applicable warnings for these errors: "7 application watch out! limited stability of the products! too strong force applications lead to damage, impair the function and thus endanger the patient.Products immediately before and after application for damages, loose check parts and completeness.No missing parts may remain in the patient.Products that are damaged, incomplete or have loose parts, do not more.8 control watch out! caution with damaged and incomplete products! injuries to the patient, user and third parties are possible.Carry out checks before and after each application.Products which are damaged and incomplete or which have loose parts, do not more.Return damaged products with loose parts for repair.Do not attempt repairs yourself.8.1 visual inspection check instruments, especially in the distal area, and accessories for damage: damage to the instrument tip (4) to avoid urethral trauma.Surface changes (e.G.Corrosion), sharp edges, loose or missing parts, rough surfaces." possible hazards were considered in the risk assessment a1 rev.05 with the corresponding extent of damage and probability of occurrence.The period (b)(6) 2016 to (b)(6) 2019 was subjected to a closer examination of the complaints database.During this period the 8703534 ureterorenoscope 12¿ 8/9.8ch nl 430mm was sold (b)(4) times, and in the observation period there was a similar case.The investigation revealed that there was no common cause for these two cases.There is so far a similar case where the cladding tube of the 8703534 ureterorenoscope was reported to have snapped off during application.In both cases there was no product or production related root cause.The investigation in both cases showed that the damage caused to the product was due to mechanical overload.As a result, no further action is currently being taken with respect to this incident other than the monitoring of further cases to establish a possible trend.The product has been tested.No product or manufacturing related problems were found.It is not comprehensible that the product was so severely bent inside the patient.According to our investigation, the damage was caused by mechanical overload.Based on a review of the complaint database, no trends or systemic problems related to a product problem are reported.The examination of the production documents also shows no deviations or anomalies.Therefore, with the exception of the monitoring of further cases in order to determine a possible trend, no further measures are currently being taken with regard to this incident.Richard wolf ((b)(4)) considers this matter closed.However, imn the event (b)(4) receives any additional information a follow up report will be submitted to fda.
Event or Problem Description
It was reported that during the 1st application in the ureter, the device kinked (over guide wire, move to the ureteral center, then with gentle angulation after neutral kinking of the ureteroscope) the application could not be terminated, because kinked device could no longer be used.

• Brand Name: E-LINE URETERORENOSKOP 12° 8/9,8CH NL 430MMH 1,6MM STANZE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10201175
• Report Number: 9611102-2019-00028
• Device Sequence Number: 2612913
• Product Code: FGB
• UDI-Device Identifier: 04055207020104
• UDI-Public: 04055207020104
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K963855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 8703.534
• Device Catalogue Number: 8703.534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1