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

Model Number	A60800A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer site investigation is ongoing and olympus (b)(4) is arranging to send a trained inspector onsite to perform the customer's requested inspection of their devices.The device has not been returned for evaluation.If additional information becomes available following device evaluation and investigation a supplemental report will be filed.
Event or Problem Description
It was reported that after a lapascropic cholecystectomy procedure was performed and completed (initial surgery performed on (b)(6) 2019), the patient returned and complained of pain around a month later.The patient had an x-ray and a foreign object was identified.Follow up surgery was performed on the patient on (b)(6) 2019.The foreign device part was removed through lapascropic procedure.This complaint is against the shaft device used during the initial procedure and this is one of the devices that the customer believes that was found in the patient.The facility requested manufacturers of all devices potentially involved in the original procedure to inspect their devices.

• Brand Name: SHAFT "HIQ+", 5 X 330 MM
• Common Device Name: INLINE, MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 9476384
• Report Number: 9610773-2019-00180
• Device Sequence Number: 2763719
• Product Code: HET
• UDI-Device Identifier: 04042761009843
• UDI-Public: 04042761009843
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: A60800A
• Device Catalogue Number: A60800A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention