MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,user facility report with the FDA on 2020-01-29 for INNER SHEATH ONLY 27050CA manufactured by Karl Storz Se & Co. Kg.
[181724282]
Per the customer, the item will not be returned for evaluation at this time.
Patient Sequence No: 1, Text Type: N, H10
[181724283]
Per medwatch report, #mw5091908, received on1/6/2020, during a bilateral lithotripsy with left ureteral stent placement procedure, the physician noticed the gray tip was fragmented during use. He found 2 pieces which were retrieved from the patient. The instrument was exchanged out and the procedure was completed with no harm to the patient. They used fluoroscopy to ensure no additional pieces were left inside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2020-00012 |
| MDR Report Key | 9645089 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 EAST GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNER SHEATH ONLY |
| Generic Name | INNER SHEATH |
| Product Code | FBO |
| Date Received | 2020-01-29 |
| Model Number | 27050CA |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |