MAUDE Adverse Event Report: GYRUS ACMI, INC. 7FR FIXEDPIN HEMOSTATIC PROBE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	CD-B622LA
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned at olympus hongkong service business center (ohc sbc).The device is being shipped to the legal manufacturer for evaluation.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that the device was used for a procedure (an unspecified), after use, the nurse helped to take it out from the scope and the ceramic tip fell off on the trolley when the nurse was gently cleaning the tip.There was no patient involvement on this reported event.No harm was reported, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on response to follow up.Communication with the customer via company representative, the following information conveyed: the procedure performed were both diagnostic and therapeutic.The subject device was inspected prior to use.Per the reporter, "the ceramic tip can be found in the preparation trolley and the tip will be returned together with the probe for further analysis".No other information was provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: d9, h3, h6 and h10.The e1 "telephone number" and e3 fields were corrected based on information available at the time of the initial submission.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.The tip ceramic tip of the device was noted to be off the device and was returned with.The distal tip was indeed broken off, the ceramic tip broke off in one single piece, there appeared to be no damage to the sheathing.The rest of the device appeared to have no damage or issues.When looking down the distal tip, it appeared to have some sort of black biomaterial or burnt adhesive.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, the use of excessive force by the customer during cleaning caused the ceramic tip to break off.Olympus will continue to monitor field performance for this device.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17103896
• Report Number: 3011050570-2023-00065
• Device Sequence Number: 19526441
• Product Code: KNS
• UDI-Device Identifier: 00821925039452
• UDI-Public: 00821925039452
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K123319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2023

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: CD-B622LA
• Device Lot Number: KR246651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 06/14/2023; 09/28/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/15/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown