MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-21 for N.A. 27023FM manufactured by Karl Storz Gmbh & Co. Kg.
[86890307]
Patient Sequence No: 1, Text Type: N, H10
[86890308]
The end of the flexible grasping forceps broke off into the patient's bladder. We removed the long end and used another cystoscope and grasper to look for it. Doctor looked and looked for it, found it once but was unable to remove it. He said the patient should pass it on his own because it is smaller than the stones that were coming out. From op report: i used a small flexible grasper through the flexible scope but that grasper failed. The grasper broke and i was unable to retrieve it without removing the flexible scope. Therefore i removed the flexible scope and used a rigid scope and performed cystoscopy. I was able to grasp the stent easily with that and remove stent. I then inspected the flexible scope and i noted that a tiny piece of the flexible grasper was not present on the grasping device. I presumed that this small piece which was only 1 mm in length and less than a millimeter in width was still in the patient's bladder. I inspected the bladder and was able to find this missing piece which is very small. If it is in his bladder it should be small enough to pass as it is smaller than the fragments that we expected pass with the lithotripsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6882164 |
| MDR Report Key | 6882164 |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-09-13 |
| Report Date | 2017-09-15 |
| Date Reported to FDA | 2017-09-15 |
| Date Reported to Mfgr | 2017-09-15 |
| Date Added to Maude | 2017-09-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | N.A. |
| Generic Name | URETHROSCOPE |
| Product Code | FBO |
| Date Received | 2017-09-21 |
| Model Number | 27023FM |
| Lot Number | PT02 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-21 |