MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number A0393

Device Problems Break (1069); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The cable was manufactured in august 2018, therefore it was used approximately 1 year.Manufacturing and quality control review was performed and no non-conformities or deviations regarding the described issue were noted.The supplier states that the cable probably broke because of wearing.The cause of the reported event cannot be determined at this time.If additional information becomes available, a supplemental report will be filed accordingly.

Event Description

The company representative stated that he received information from the user facility the during a procedure the device sparked and broke off at the end.There was no injury reported.

Manufacturer Narrative

The customer returned an a0393 high frequency cable lot number 741 764 for an evaluation for ¿sparked and broke off at the end.¿ a visual inspection of the received condition was performed on the device; the generator connector side of the hf cable is detached and separated.The breakage was examined under a microscope; charred and burned marks noted.No damage on the instrument connector side of the hf cable.Based on the evaluation, the a0393 high frequency cable was damaged.The generator connector side of the hf cable was detached and separated.Charred and burned marks observed on the breakage.Based on similar reported complaints, the most probable cause to the damage is the device was mishandled.The ifu warns of damaging the cable.In order to plug or unplug the cable always pull at the plug.Never pull at the cable.¿ it is likely the hf cable was initially damaged and partially separated from the generator connector, although not completely detached.Upon activation, due to insufficient conductive material, the portion of the wire that was open and separated produced an electrical arc due to the close proximity of the two connections combined with the high power and frequency of the output energy of the generator, resulting in the ¿sparked¿ reported by the users¿ experience.

• Brand Name: HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8997629
• MDR Text Key: 193769018
• Report Number: 9610773-2019-00120
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Catalogue Number: A0393
• Device Lot Number: 829421
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1