MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY THERMOFLATOR; INSUFFLATOR

Model Number	26432020-1
Health Effect - Clinical Codes	Hematoma (1884); Laceration(s) (1946)
Date of Event	03/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is being returned for evaluation but has not yet been received.
Event or Problem Description
Allegedly, the patient underwent a laparoscopic procedure and while being insufflated, the hospital claims the thermoflator unit somehow created a vacuum situation, causing the veress needle to perforate/lacerate a blood vessel, creating a hematoma which they were able to evacuate.The patient was admitted overnight and was discharged the following day.

• Brand Name: THERMOFLATOR
• Common Device Name: INSUFFLATOR
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen
• MDR Report Key: 6473587
• Report Number: 9610617-2017-00028
• Device Sequence Number: 849944
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 4048551069264
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K955073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2017
• Report Date (Section F): 04/07/2017

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: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• 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: Required Intervention
• Patient Age: 17 MO
• Patient Weight: 11