MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-03-16 for REUSABLE MONOPOLAR ELECTRODE 8416031 manufactured by Richard Wolf Germany (rwgmbh).
[102860669]
Unable to investigation/evaluation due to actual device not being returned to manufacturer and no lot number supplied by user facility. Facility was contacted in an effort to gather missing medwatch information, the device in question and/or photos or videos of the device. No response as of yet. Richard wolf (b)(4) ((b)(6)) considers this matter closed. However, in the event (b)(6) receives any additional information a follow up report will be submitted to fda. Richard wolf medical instruments corporation (rwmic) submitting report on behalf of (b)(4) report on behalf of (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102860670]
Suspect device was used on a tumor on a childs small intestine. The loop completely degraded and was never found again. Procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2018-00004 |
| MDR Report Key | 7347249 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-03-16 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-16 |
| 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 GERMANY (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 | 3 |
| Brand Name | REUSABLE MONOPOLAR ELECTRODE |
| Generic Name | MONOPOLAR ELECTRODE |
| Product Code | JOS |
| Date Received | 2018-03-16 |
| Model Number | 8416031 |
| Catalog Number | 8416031 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-03-16 |