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

Catalog Number A6282

Device Problems Crack (1135); Fracture (1260)

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

Event Date 06/25/2015

Event Type  malfunction  

Event Description

Olympus was informed that at the end of an unspecified therapeutic laparoscopic surgery procedure, the surgical team noticed that the ceramic insulation at the distal end of the hf electrode's sheath had broken/fractured and was partially missing.It is unknown when exactly this damage occurred and whether a fragment/part fell inside the patient's body cavity.However, it was reported that the ceramic insulation already had a crack when the procedure was started.No other information was provided but the intended procedure was subsequently completed with the same hf electrode and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on (b)(6) 2015).The evaluation/investigation confirmed the reported phenomenon of a broken/fractured ceramic insulation at the distal end of the hf electrode's sheath.At least one fragment/part is broken out and missing.Causal for this damage and the subsequent breakage of the ceramic insulation is mechanical overload by the application of excessive force like impact, fall, shock or similar stress.Furthermore, there are clearly visible brown discolorations and residues at the distal end, and a burn mark/dent at the hook/tip of the suspect medical device.Causal for these abnormalities are improper and/or incomplete reprocessing (discolorations/residues) in combination with thermal overload (burn mark/dent).As clearly stated in the instructions, the product has to be visually inspected before use.It has to be ensured that it has no signs of wear, no damage or distortion of the distal end and no damaged insulation.Furthermore, it is pointed out as a warning note that impact, fall, shock or similar stress can result in damage of the ceramic insulation at the sheath's distal end and that the instrument must not be used if damaged as otherwise this can cause injuries of the patient and/or user.The product must be properly reprocessed before first and each subsequent use, following the instructions in the manual and in the olympus endoscopy system guide.In addition, it is pointed out as a caution note that, when used as intended, the product is more or less subject to wear, depending on the intensity of use.In case of externally visible defects, the responsible olympus representative has to be contacted at once.The user apparently did not follow these instructions as the damage of the hf electrode and the subsequent breakage of the ceramic insulation were caused by mechanical overload by the application of excessive force like impact, fall, shock or similar stress.Furthermore, the suspect medical device was reportedly used despite clearly visible discolorations and residues, caused by improper and/or incomplete reprocessing.Therefore this event/incident was attributed to abnormal use/off-label use in combination with exceeded service life/shelf-life.The case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and pro re nata trained again on the correct usage and reprocessing of the olympus medical devices.

• Brand Name: HF-ELECTRODE, HOOK, 5 X 330 MM
• Type of Device: HF ELECTRODES, RIGID
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 2204 5; GM 22045
• Manufacturer (Section G): BOWA-ELECTRONIC GMBH & CO. KG; heinrich-hertz-strasse 4-10; gomaringen, 7281 0; GM 72810
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 4066966
• MDR Report Key: 4897831
• MDR Text Key: 6022555
• Report Number: 9610773-2015-00028
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K923982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• 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: 311280
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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