MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for DISCOSCOPE 89210.1254 manufactured by Richard Wolf Gmbh.
[131796743]
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.
Patient Sequence No: 1, Text Type: N, H10
[131796744]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2018-00049 |
| MDR Report Key | 8166400 |
| Date Received | 2018-12-14 |
| Date of Report | 2018-11-15 |
| Date Facility Aware | 2018-11-15 |
| Report Date | 2018-12-14 |
| Date Reported to FDA | 2018-12-14 |
| Date Reported to Mfgr | 2018-12-14 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2018-12-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. OLIVER EHRLICH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISCOSCOPE |
| Generic Name | DISCOSCOPE |
| Product Code | GCM |
| Date Received | 2018-12-14 |
| Returned To Mfg | 2018-11-21 |
| Model Number | 89210.1254 |
| Catalog Number | 89210.1254 |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-14 |