MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-10-25 for SEALING CAP, BLACK, 0-2 MM 89.00 manufactured by Richard Wolf Germany (gmbh).
[58357925]
A full investigation could not be completed as the actual device was not returned to the richard wolf (b)(4) facility as of 10/25/2016; however, a poor quality photo of seal was submitted. Product may have been used longer than normal which may have caused it to become less pliable and rip when a sharp instrument was introduced. Unable to determine the root cause of customer's complaint. Labeling was reviewed and found to be adequate, ie intended use, indications and field of use, preparation and cautions. Reports on this device were reviewed, no trends were noted. (b)(4) considers this matter closed. However, in the event we receive the device or additional information is received, (b)(4) will provide fda with follow-up information. (b)(4). Actual device not returned.
Patient Sequence No: 1, Text Type: N, H10
[58357926]
Richard wolf (b)(4) was notified about a device that tore during a procedure. Specifically, after an endoscopic rhizotomy procedure 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 (approx 3 mm in diameter). 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. A full investigation could not be completed at this time as the actual device was not returned to the (b)(4) facility as of 10/25/2016, only a poor quality photo of the device has been received. Unable to determine lot # based on photo. However based on sales records, the following is the information on the last sealing cap purchased by user facility: lot #51001511, qty - 1 package (10 seals/package), date purchased - (b)(6) 2014, manufacturing date - 04/2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2016-00015 |
| MDR Report Key | 6054556 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-10-25 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-09-28 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2016-10-25 |
| 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 GERMANY (GMBH) |
| Manufacturer Street | REGISTRATION #9611102 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 | SEALING CAP, BLACK, 0-2 MM |
| Generic Name | SEALING CAP |
| Product Code | GCM |
| Date Received | 2016-10-25 |
| Model Number | 89.00 |
| Catalog Number | 89.00 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-10-25 |