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 2017-04-14 for COLD KNIFE 27033W-S manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[72877014]
Scope 27033aa is the model number listed on the original medwatch ((b)(4)) filed by the hospital. During follow up with the doctor, we learned that a sickle cold knife was being used when injury occurred which we believe was a 27033w-s. There was no report of malfunction. The hospital did not return the device. Hospital could not find.
Patient Sequence No: 1, Text Type: N, H10
[72877075]
Allegedly, the patient was scheduled for a cystoscopy with transurethral incision of posterior urethral valves and circumcision. During cystoscopy, patent became hemodynamically unstable and procedure was stopped. The patient was stabilized and transferred to pediatric intensive care unit (picu) where he continued to decompensate. After approximately 3 hours, he returned to the operating room for a stat exploratory laparotomy and it was discovered that the left iliac vein and artery was lacerated. The vessels were immediately clamped to control bleeding. The vascular team was contacted and the artery was repaired without difficulty. The patient improved immediately and was readmitted to the picu for four days. He was later transferred to an inpatient room and discharged eleven days after admission.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00029 |
| MDR Report Key | 6494698 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-13 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2017-03-15 |
| Date Added to Maude | 2017-04-14 |
| 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 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 | COLD KNIFE |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2017-04-14 |
| Model Number | 27033W-S |
| Catalog Number | 27033W-S |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 1. Hospitalization | 2017-04-14 |