MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DISSECTING ELECTRODE, L -SHAPED

Model Number	26870UFS
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has not returned product 26870ufs for evaluation.The date code per the medwatch report we received from the customer is uu which indicates the manufactures date of july 2015.The facility was shipped the product in october of 2015 approximately 4 years ago.The product will not be returned for evaluation.
Event or Problem Description
Allegedly per the customer, during an appendectomy the surgeon noticed a small 1-2 mm partial thickness burn on the cecum.Per surgeon the burn came from the insulation of the electrocautery device.The procedure was completed.

• Brand Name: DISSECTING ELECTRODE, L -SHAPED
• Common Device Name: DISSECTING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9184966
• Report Number: 9610617-2019-00096
• Device Sequence Number: 19567299
• Product Code: GEI
• UDI-Device Identifier: 04048551072578
• UDI-Public: 4048551072578
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K944796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26870UFS
• Device Catalogue Number: 26870UFS
• Device Lot Number: UU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/14/2019
• 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: 11 YR
• Patient Weight: 29