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

Model Number 33151

Device Problem Material Erosion (1214)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/14/2017

Event Type  Injury  

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 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
• Type of Device: HANDLE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188519
• MDR Report Key: 6749123
• MDR Text Key: 81229910
• Report Number: 9610617-2017-00061
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551009369
• UDI-Public: 4048551009369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 33151
• Device Catalogue Number: 33151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR