MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH PREPARATION FORCEPS "HIQ+", BIPOLAR, 5 X 330 MM, MARYLAND, SHORT, ERGO

Model Number	WA63320C
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined; however, the (b)(4) instruction manual warns users ¿only use the jaws¿ front part for coagulation.Make sure not to touch the tissue with the jaws¿ non-insulated joint area.Otherwise, there is the risk of accidental coagulation.".
Event or Problem Description
Olympus was informed that during a therapeutic laparoscopic hysterectomy procedure, the grasping forceps were transmitting thermic energy resulting in involuntary burning and coagulation of adjacent tissues.It is unknown if the intended procedure was completed.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received.Olympus received additional information that states the hand-piece was activated no more than 20 seconds at a time.The patient¿s uterus was burned while cauterizing a uterine artery.No additional surgical intervention was required.

• Brand Name: PREPARATION FORCEPS "HIQ+", BIPOLAR, 5 X 330 MM, MARYLAND, SHORT, ERGO
• Common Device Name: PREPARATION FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 8242576
• Report Number: 2951238-2019-00362
• Device Sequence Number: 13812896
• Product Code: GEI
• UDI-Device Identifier: 04042761063050
• UDI-Public: 04042761063050
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA63320C
• Device Catalogue Number: WA63320C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/14/2019
• 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: Other