MAUDE Adverse Event Report: RICHARD WOLF GMBH NEPHROSCOPE 20° 24FR. WL 224MM RIGID WITH LATERAL OCULAR LENS WORKING CHANNEL; NEPHROSCOPE 20° 24FR WL224MM

Model Number	8965.411
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation / evaluation currently in process.Rw (b)(4) considers this report open, follow-up report to be submitted once investigation is complete.Richard wolf medical instruments corporation (rwmic) is submitting this report on behalf of richard wolf (b)(4).Rw (b)(4) is manufacturer.
Event or Problem Description
At the first ten minutes of the operation the nephroscope 8965.411 was excellent and then we started the second operation and vision began to disappear gradually the same day.Unfortunately the operation was not completed.Manufactured date: 08 march 2018.Lot size: (b)(4) units.Purchase date: (b)(6) 2018.
Event or Problem Description
Follow up report to provide additional information to fda.
Additional Manufacturer Narrative
(b)(4).To obtain optimum light transmission, the diameters of the fibre bundle of the endoscope and of the fibre light cable must be the same.Possible causes when using a fibre light cable that is too small: the light output is reduced.Caution! increased danger potential if image is blurred! patient may be injured.Stop operation for safety reasons if image is blurred.Check image quality of endoscope before use.Caution! do not work outside the scope's field of view! inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts can occur.Check image quality and light output in conjunction with the system components.An investigation was unable to be performed as the device was not returned to the manufacturer.Multiple attempts were made to contact the user facility, but no response was provided.Richard wolf gmbh (rwgmbh) considers this matter closed.In the event rwgmbh receives additional information a follow up report will be submitted to fda.

• Brand Name: NEPHROSCOPE 20° 24FR. WL 224MM RIGID WITH LATERAL OCULAR LENS WORKING CHANNEL
• Common Device Name: NEPHROSCOPE 20° 24FR WL224MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strabe 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 7550175
• Report Number: 9611102-2018-00010
• Device Sequence Number: 2324031
• Product Code: FGA
• UDI-Device Identifier: 04055207023327
• UDI-Public: 04055207023327
• Combination Product (Y/N): N
• Initial Reporter Country: YM
• PMA/510(K) Number: K994223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: No Information
• Device Model Number: 8965.411
• Device Catalogue Number: 8965.411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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: Other
• Patient Age: 21 YR
• Patient Weight: 61