MAUDE Adverse Event Report: RICHARD WOLF GMBH DISCOSCOPE

Model Number	89210.1254
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic considers this case open.Rwmic will follow up with the user facility and manufacturer to obtain additional and missing information.(b)(4).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.Check image quality and light output: deposits on the glass surfaces can result in a stained or blurred field of view and can considerably impair light transmission.
Event or Problem Description
On (b)(4) 2018, the user facility reported the following to richard wolf medical instruments corporation (rwmic): while being used on a patient, the staff noticed the scope was blurry and they had to grab another device to complete the device.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.User facility returned the device to rwmic on november 21, 2018, and the evaluation was completed on november 30, 2018.The device appeared to be used - housing was bent and dented and there was moisture in the optic system.The reported condition was verified using visual and functional testing.It was determined that the scope may have been dropped.The root cause was determined to be user handling issues.A manufacturing defect was not identified.
Additional Manufacturer Narrative
Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.
Event or Problem Description
Follow-up report #1 is to provide fda with new and changed information.

• Brand Name: DISCOSCOPE
• Common Device Name: DISCOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8166400
• Report Number: 1418479-2018-00049
• Device Sequence Number: 2142380
• Product Code: GCM
• UDI-Device Identifier: 04055207035054
• UDI-Public: 04055207035054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018
• Report Date (Section F): 04/26/2019

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: No Information
• Device Model Number: 89210.1254
• Device Catalogue Number: 89210.1254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/15/2018
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 04/26/2019
• 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
• Date Report Sent to FDA: 04/26/2019