MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-17 for CYSTOSCOPE-URETHROSCOPE SHEATH 27026CA manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[73027661]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[73027662]
Allegedly, during a cystoscopy procedure the surgeon noticed the tip of the sheath was gone. He located the piece in the patient's bladder but was unable to retrieve it. Patient was admitted to the hospital and then returned to surgery the next day for an open procedure wherein the tip was retrieved. The hospital did not report injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[75642863]
The device was not returned to us, but we did receive pictures. In the first picture, the labeling was worn and blurry and showed a date code of uw. The second picture shows that the beak is completely detached from sheath; the whole beak coming out is a failure of adhesion/fixation and we see it often on 3rd party repaired devices. The hospital confirmed that they use 3rd party repair. The third picture shows the whole instrument and the shaft is bent. Damage possibly due to wear of use and/or 3rd party repair of instrument; we cannot confirm. Karl storz does not approve of any 3rd party repair and does not provide replacement parts.
Patient Sequence No: 1, Text Type: N, H10
[75642904]
This is a supplemental. We were unable to get the product back, but we did receive pictures. We are providing an evaluation based on the pictures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00032 |
| MDR Report Key | 6499083 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-17 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-03-15 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2017-04-17 |
| 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 | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188519 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYSTOSCOPE-URETHROSCOPE SHEATH |
| Generic Name | CYSTOSCOPE-URETHROSCOPE SHEATH |
| Product Code | ODB |
| Date Received | 2017-04-17 |
| Model Number | 27026CA |
| Catalog Number | 27026CA |
| Lot Number | UW |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |