MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-29 for RESECTOSCOPE SHEATH 86613741 manufactured by Richard Wolf Gmbh.
[30273116]
Device recently received device and investigation is currently inprocess. (b)(4) considers this report open and follow-up report to be sent at a later time.
Patient Sequence No: 1, Text Type: N, H10
[30273117]
Facility reported that a device arched and damaged the tip of a second device being used during the procedure. The two impacted devices were swapped out to back up devices, readily available for use, and procedure was completed as scheduled. No injury to patient or staff reported. At least six devices are assembled together in order to operated. The two devices which had product problems and their associated mdr's are: sheath (8661. 3741) - mdr9611102-2015-00004 (tip damaged). Electrode (8424. 141) - mdr9611102-2015-00005 (device arched).
Patient Sequence No: 1, Text Type: D, B5
[32268787]
Investigation has now been completed, this follow-up is notification of results. The actual device was returned to (b)(4) for investigation on (b)(4) 2015. The ceramic tip of the sheath had pieces broken off from the distal tip. The device was sent in together with the electrode that was being used during the time of the issue. Distal end of the electrode was missing approximately 15mm of insulation most likely the source of current causing damage to ceramic tip of sheath. Labeling was reviewed and found to be adequate. Ie intended use, indications and field of use, preparation and cautions regarding high temperatures and use of irrigation fluid. (b)(4) considers this matter closed. However, in the event (b)(4) receives additional information, a follow-up report will be provided to fda.
Patient Sequence No: 1, Text Type: N, H10
[32268788]
This is a follow-up #1
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2015-00004 |
| MDR Report Key | 5186420 |
| Date Received | 2015-10-29 |
| Date of Report | 2015-10-28 |
| Date of Event | 2015-05-11 |
| Date Mfgr Received | 2015-09-29 |
| Device Manufacturer Date | 2013-04-19 |
| Date Added to Maude | 2015-10-29 |
| 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 | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer Phone | 043351013 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| 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 | RESECTOSCOPE SHEATH |
| Generic Name | SHEATH |
| Product Code | FDC |
| Date Received | 2015-10-29 |
| Returned To Mfg | 2015-10-13 |
| Model Number | 86613741 |
| Catalog Number | 86613741 |
| Lot Number | 1211303 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-29 |