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 2016-03-24 for RIGID ENDOSCOPE SHEATH 8680.224 manufactured by Richard Wolf Gmbh.
[41047303]
Richard wolf (b)(4) has not received actual device or photos of device as of 03/25/2016. There have been no similar incidents reported on this product. (b)(4) considers this report closed. If (b)(4) receives any new information a follow up report will be sent to fda. (b)(4). Not returned.
Patient Sequence No: 1, Text Type: N, H10
[41047304]
During surgery, the handpiece suddenly divided into two parts, the operation could not proceed normally, so the operation has to be stopped while the doctor took out the broken part from the body of the patient. Because the surgical instrument was damaged during operation, the hospital had to use an alternate system to continue and complete the procedure. As surgery prolonged, patient had excessive bleeding, patients had been given 400ml blood transfusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2016-00014 |
| MDR Report Key | 5522606 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-03-24 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2014-12-12 |
| Date Added to Maude | 2016-03-24 |
| 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 | RIGID ENDOSCOPE SHEATH |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2016-03-24 |
| Model Number | 8680.224 |
| Lot Number | 1260601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2016-03-24 |