MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-23 for RESECTOSCOPE, WORKING ELEMENT 86592351 manufactured by Richard Wolf Germany (rwgmbh).
[103689555]
Investigation/evaluation currently in process. (b)(4) considers this report open, follow-up report to be submitted once investigation is complete. Richard wolf medical instruments corporation (rwmic) submitting report on behalf of richard wolf (b)(4) (rw(b)(4)) (manufacturer).
Patient Sequence No: 1, Text Type: N, H10
[103689556]
Richard wolf (b)(4) (rw(b)(4)) was notified by user facility that during a procedure the tip of the sheath broke into pieces and fell into the patient. Pieces were recovered from patient. Facility also reported burn marks on the working element and damaged electrode. At this time, the working element and sheath are suspect devices and a report will be submitted for each device. Working element (id #(b)(6)) (mdr 9611102-2018-00007); outer sheath (id #(b)(6)) (mdr 9611102-2018-00006). Working element manufactured on 17oct2017 with a batch size of 5 units. Sheath was purchased by facility on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2018-00007 |
| MDR Report Key | 7367700 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-23 |
| Date of Report | 2018-02-26 |
| Date Mfgr Received | 2018-06-27 |
| Device Manufacturer Date | 2017-10-17 |
| Date Added to Maude | 2018-03-23 |
| 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. HEIKO SIEDER-BIEDERMANN |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GERMNY (RWGMBH) |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| 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 | RESECTOSCOPE, WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2018-03-23 |
| Returned To Mfg | 2018-03-05 |
| Model Number | 86592351 |
| Catalog Number | 86592351 |
| Lot Number | 1353412 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GERMANY (RWGMBH) |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-23 |