MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SHAFT "HIQ+", 5 X 330 MM; SURG, EN

Model Number	A60800A
Medical Device Problem Codes	Material Deformation (2976); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation and repair.The investigation is still in progress.Therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects.Check the function of all devices.And have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported to olympus, that during the operation.It became impossible to grasp with abnormal noise.Completed by replacing with similar equipment.No health hazard to patient.The shaft of the unit was separated from the moving part of the jaw and did not interlock with the handle operation.Checked the shaft for deformation.Fracture surface was not visible.No additional information has been obtained at the moment.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide corrections to the following fields: b1, b2, h1.This supplemental report is being submitted to provide clarification to the following fields: b5, d10, g2, h6.
Event or Problem Description
It was also stated that the at the time of the report, the hospital could not confirm the parts had not been retained in the patient, and it was being treated as if the devices had fallen into a body cavity.Additional information was requested multiple times, but was not received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the shaft defect is attributable to excessive force.Also, it can be assumed that the reported abnormal noise has no relation to the deformation of the shaft.This supplemental report includes a correction to d4 and g2.Also, new information has been added to h4.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction with information inadvertently left out (b5 and h4).
Event or Problem Description
This event involved 3 devices.Patient identifier (b)(6) is for the jaws "hiq+", 5 x 330 mm, grasping forceps, croceolmi.Patient identifier (b)(6) is for the shaft "hiq+", 5 x 330 mm.Patient identifier (b)(6) is for the handle "hiq+", ergo s, unipolar.

• Brand Name: SHAFT "HIQ+", 5 X 330 MM
• Common Device Name: SURG, EN
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16882111
• Report Number: 9610773-2023-01229
• Device Sequence Number: 20698164
• Product Code: HET
• UDI-Device Identifier: 04042761009843
• UDI-Public: 04042761009843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944200
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A60800A
• Device Catalogue Number: A60800A
• Device Lot Number: 21814-0023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 08/04/2023; 09/01/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/11/2023; 08/14/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE "HIQ+", ERGO S, UNIPOLAR ¿ LOT 21702-0007.; JAWS "HIQ+", 5X330MM,GRASP FORCEPS-LOT 21Z02-014.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown