MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for SEALING CAP, BLACK, 0-2 MM 89.00 manufactured by Richard Wolf Germany (gmbh).
[46472231]
(b)(4) was notified by company representative about a device that tore during a procedure. Specifically, after a rhizotomy case was completed, the spine endoscope with all of its attachments and adaptors was disassembled. A black sealing cap was observed to have a small piece torn off. All of the surrounding area was immediately searched and the piece was not found. Procedure completed and no injury to patient or staff was reported. No similar issues have been reported to (b)(4), on this product, in the last three years. A request has been sent to facility in order to gather additional information needed for this report, no response as of 06/02/2016. A full investigation could not be completed at this time as the actual device was not returned to the (b)(4) facility as of 06/02/2016. (b)(4) considers this report to be closed. However, in the event (b)(4) receives the device or additional information, it will be forwarded on to manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[56463457]
Follow up report to change manufacturer from da/pro to (b)(6) gmbh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2016-00016 |
| MDR Report Key | 5696059 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-05-04 |
| Date Facility Aware | 2016-05-05 |
| Report Date | 2016-09-28 |
| Date Reported to FDA | 2016-06-02 |
| Date Reported to Mfgr | 2016-09-28 |
| Date Added to Maude | 2016-06-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEALING CAP, BLACK, 0-2 MM |
| Generic Name | SEALING CAP |
| Product Code | GCM |
| Date Received | 2016-06-02 |
| Model Number | 89.00 |
| Catalog Number | 89.00 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GERMANY (GMBH) |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, OK 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |