MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for SHEATH, INNER CFR, 22.5 FR. 8655.3441 manufactured by Richard Wolf Germany (gmbh).
[73399119]
Facility notified (b)(4) on (b)(6) 2017 and relayed that during a case the beak broke off and no injuries had occurred. (b)(4) sales representative was contacted and indicated beak broke into pieces however they were retrieved and procedure completed as scheduled. The removal of the foreign objects cause a delay in the procedure that may have resulted in patient being at risk. (b)(4) also received a medwatch report ((b)(4)) on 04/10/2017, indicating that during a hysteroscopy procedure device broke inside of body cavity. No injuries to patient or staff were reported. No similar issues on this device in the last three years resulting in a medical device report. Manufacture date : 08/2012. Purchase date: (b)(6) 2013. User facility was contacted for missing and additional information on several occasions, no information received as of 04/20/2017. (b)(4). (b)(4) considers this report closed. If any additional information is received a follow up report will be sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2017-00007 |
| MDR Report Key | 6508219 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-03-20 |
| Date Facility Aware | 2017-03-23 |
| Report Date | 2017-04-20 |
| Date Reported to FDA | 2017-04-20 |
| Date Reported to Mfgr | 2017-04-20 |
| Date Added to Maude | 2017-04-20 |
| 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 | SHEATH, INNER CFR, 22.5 FR. |
| Generic Name | INNER SHEATH |
| Product Code | FDC |
| Date Received | 2017-04-20 |
| Returned To Mfg | 2017-04-04 |
| Model Number | 8655.3441 |
| Catalog Number | 8655.3441 |
| Lot Number | 1186685 |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GERMANY (GMBH) |
| Manufacturer Address | REGISTRATION #9611102 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |