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

Model Number	A6282
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: device evaluation: 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 2021-05-19).The evaluation/investigation confirmed a damaged coating and a crack in the ceramic part.The cause of this damage is most likely age-related wear and tear.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf-electrode without showing any abnormalities.The case will be closed from olympus side with no further actions, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during a therapeutic laparoscopic cholecystectomy procedure, the coating of the handle chipped and fell into the patient¿s body cavity.However, no fragments remained inside the patient since they were reportedly retrieved after an intra-abdominal lavage was performed.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.

• Brand Name: HF-ELECTRODE, HOOK, 5 X 330 MM
• Common Device Name: HF ELECTRODES, RIGID
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11759110
• Report Number: 9610773-2021-00129
• Device Sequence Number: 4492146
• Product Code: GCJ
• UDI-Device Identifier: 04042761028868
• UDI-Public: 04042761028868
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A6282
• Device Catalogue Number: A6282
• Device Lot Number: 632108
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1