MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT; NEEDLE HOLDERS

Model Number	WA64700A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus (although it is anticipated).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports, during an unspecified diagnostic procedure using a jaws ("hiq+", 5 x 330 mm, needle holder, straight), the tip of the device broke off and into the patient.It is unknown if/how the device fragment was retrieved.It is unknown where in the patient's body the device fragment fell.It is reported there was harm to the patient, no further details were provided.Additional information has been requested.At this time, no further detail has been provided.
Event or Problem Description
Update: additional information reported by the customer: the procedure being performed was a nephrectomy for the indication of laparoscopy.The device fragment did not fall inside the patient.There was no injury to the patient.There was no treatment/intervention required , the patient was not affected.When asked: what is the patient's current condition, the customer responded: the patient was not affected.
Additional Manufacturer Narrative
This report is being updated to provide additional information reported by the customer, corrected information and the investigation findings.Corrected information is reported in b1, d9 and h1.B1: no adverse event, only product problem.D9: device is not being returned per updated information from the customer.Hi: device malfunction.Since the product for this info complaint was not returned to olympus, our investigation is based solely on the information provided by the customer.Analysis: initially, it was reported in the event description that there was patient injury because a part fell into the patient.However, upon enquiry, it was confirmed and added to the event description that the part that broke off was not at the distal end but at the proximal end and therefore could not have fallen into the patient.In a photograph sent by the customer, the overload protection located at the proximal end of the jaw insert is cracked or the overload protection of the jaw has been properly triggered as a result of a massive overload to prevent axle breakage or similar damage to the jaw area.Kindly note that forceps with triggered overload protection are out of function and do not comply with the current product specification and cannot be used further according to the ¿intended use¿.A manufacturing defect can therefore be ruled out since the damage was caused by massive overloading.Cause: according to our investigators, the cause of the reported issue is most likely due to the application of excessive force as well as high mechanical overload.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the ifu, a suitable replacement device must be provided during an application.Dhr review: a manufacturing and quality control review was performed for device wa64700a with reported lot.There is no non-conformity associated with this device with respect to the described issue.The definitive cause of the reported event cannot be conclusively determined.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT
• Common Device Name: NEEDLE HOLDERS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14140190
• Report Number: 9610773-2022-00142
• Device Sequence Number: 3986511
• Product Code: GCJ
• UDI-Device Identifier: 04042761031097
• UDI-Public: 04042761031097
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: WA64700A
• Device Catalogue Number: WA64700A
• Device Lot Number: 20Y04-021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2021
• 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
• Patient Sex: Unknown