MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HANDLE "HIQ+", ERGO S, RATCHET; HANDLE, LATCH, PADDED

Model Number A60200A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been 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 the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified therapeutic procedure at an unknown date, the screw of the subject handle was missing after the subject handle was used in combination with a forceps.Since the screw was not detected anywhere, it is assumed that it may have fallen into the patient during the procedure.However, the intended procedure was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury.An x-ray is planned to confirm the presence of any residue in the patient¿s body.

Manufacturer Narrative

Additional information: d4 - lot number, h4 - device manufacturer date, h8 - usage of device.Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.No further information was provided on whether the missing screw was found during the announced x-ray examination.Usually, however, the corresponding device is used in conjunction with a trocar.Thus, it is very unlikely that a screw may have fallen into the patient.According to the lot number, the article was manufactured in march 2010.Therefore, in view of the long period of use of the subject device, the root cause of the reported phenomenon can most likely be attributed to use-related wear and tear in combination with an inadequate inspection of the equipment before use, i.E.Checking for proper functionality and possible damage.Since it is clearly stated in the instructions for use that the product has to be visually inspected and tested before use, 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 handle 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.

• Brand Name: HANDLE "HIQ+", ERGO S, RATCHET
• Type of Device: HANDLE, LATCH, PADDED
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10331822
• MDR Text Key: 200679478
• Report Number: 9610773-2020-00169
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761009782
• UDI-Public: 04042761009782
• Combination Product (y/n): N
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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
• Device Operator: Health Professional
• Device Model Number: A60200A
• Device Catalogue Number: A60200A
• Device Lot Number: 103W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1