MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-09-21 for TELESCOPE 12 DEGREE, 4MM A22001A manufactured by Olympus Winter & Ibe Gmbh.
[2905960]
During a three hour transurethral resection of the prostate of (b)(6) pt with bipolar resection in saline equipment, the pt? S bladder ruptured.
Patient Sequence No: 1, Text Type: D, B5
[10153310]
Upon a visit of an olympus rep at the user facility can be admitted that the instruments are working well without any indication of a malfunction. Gas collection in the bladder and the hazard of rupture caused by spark ignition is a procedure-related problem being well-described in literature and thus, can be considered a known side-effect. It is recommended to flush the bladder regularly during the procedure, consequently, this hazard has been addressed in the risk management file. As a risk mitigation measure, the ifu contains appropriate warning messages and safety advises. It is under control of the user to follow these advises and recommendations. There are strong indications for inadvertence and lack of experience of the user as the flushing was reportedly done sporadically only and a procedure of 3 hours for a prostate resection can be considered extraordinarily long. Thus, the case is assessed to be the consequence of a user error. Appropriate risk mitigation measures are in place resulting in an over-all low occurrence rate, hence, no further actions are planned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2012-00049 |
| MDR Report Key | 2759362 |
| Report Source | 05,07 |
| Date Received | 2012-09-21 |
| Date of Report | 2010-04-21 |
| Date of Event | 2010-04-14 |
| Date Added to Maude | 2012-12-26 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL PETRICH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | GM |
| Manufacturer Phone | 669662572 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELESCOPE 12 DEGREE, 4MM |
| Generic Name | TELESCOPE FOR ENDOSCOPY |
| Product Code | FBP |
| Date Received | 2012-09-21 |
| Model Number | A22001A |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-21 |