MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK, 5 X 330MM; HF ELECTRODES, RIGID

Catalog Number A6282

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

Olympus was informed that during preparation for cleaning/reprocessing after a therapeutic laparoscopic cholecystectomy procedure, the user facility staff noticed a chipped ceramic insulation at the distal end of the hf electrode's sheath.It is unk when exactly this damage occurred and whether a fragment/part fell inside the patient's body cavity during the previous procedure.No other info was provided but there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation as it was reportedly discarded by the user facility.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unk.However, a material or quality problem can be excluded as a manufacturing and quality control review was performed for the affected lot number of the hf electrode without showing any abnormalities related to function and safety.The cause will be closed from olympus side with no further actions.However, the incident/phenomenon will be recorded for trending and surveillance purposes and if additional significant info becomes available, this report will be updated.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: HF-ELECTRODE, HOOK, 5 X 330MM
• Type of Device: HF ELECTRODES, RIGID
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 0669662955
• MDR Report Key: 4524349
• MDR Text Key: 5408392
• Report Number: 9610773-2015-00006
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A6282
• Device Lot Number: 228 74
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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