MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY CLICKLINE PLASTIC HANDLE

Model Number	33151
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instrument has not been returned for evaluation yet, but the doctor described gross breeches in the insulation of the handle.The device was not inspected before the procedure for damage.We think the insulation damage resulted in arcing and caused burn.
Event or Problem Description
Allegedly, the doctor was performing a hysterectomy on a patient when the 33151 handle was laid down on the patient and the cautery activated.There were breeches in the insulation on the handle and it arced and the patient received a burn in the abdomen area.The doctor covered the burn in flamazine and had a cosmetic surgeon assess the burn; the cosmetic surgeon said it would heal nicely and no actions need be taken.Dr.(b)(6) saw her again and says the burn is healing well.He characterized it as a 2nd degree burn.

• Brand Name: CLICKLINE PLASTIC HANDLE
• Common Device Name: HANDLE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6749123
• Report Number: 9610617-2017-00061
• Device Sequence Number: 220159
• Product Code: GCJ
• UDI-Device Identifier: 04048551009369
• UDI-Public: 4048551009369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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: 33151
• Device Catalogue Number: 33151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/27/2017
• 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: Other
• Patient Age: 41 YR