MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY COLD KNIFE

Model Number	27033W-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: COLD KNIFE
• Common Device Name: COLD KNIFE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6494698
• Report Number: 9610617-2017-00029
• Device Sequence Number: 11008224
• Product Code: EZO
• UDI-Device Identifier: 04048551393062
• UDI-Public: 4048551393062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 27033W-S
• Device Catalogue Number: 27033W-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 1 MO
• Patient Weight: 4