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

Model Number	WA64700A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome 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 or Problem Description
Olympus was informed that during a therapeutic laparoscopic hysterectomy procedure, the tip of the needle snapped and fell into the patient¿s abdomen.X-rays were performed on the table and the fragment was retrieved with the assistance of the general surgeon.The patient had to be kept under anesthetics for more than three hours.No further information was provided but there was no report about a malfunction of an olympus medical device.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the immobile jaw part of the needle holder is broken off.The surfaces of the fracture show slight corrosion.The cause of this damage is most likely material fatigue caused by acute wear and tear.In view of the age of the product, it is assumed that the article, which, according to its product specification, is designed for 400 reprocessing and ultrasonic cleaning cycles, was used far beyond its expected service life.Furthermore, the remaining jaw part shows clear pressure marks outside the carbide plate and the pull rod is strongly deformed.This damage was most likely caused by improper handling.Thus, this event/incident was attributed to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the needle holder without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
Event or Problem Description
Olympus was informed that during a therapeutic laparoscopic hysterectomy procedure, the tip of the needle holder snapped and fell into the patient¿s abdomen.X-rays were performed on the table and the fragment was retrieved with the assistance of the general surgeon.The patient had to be kept under anesthetics for more than three hours.No further information was provided.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT
• Common Device Name: NEEDLE HOLDERS (HANDLES, JAWS INSERTS)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11846864
• Report Number: 9610773-2021-00139
• Device Sequence Number: 16934210
• Product Code: GCJ
• UDI-Device Identifier: 04042761031097
• UDI-Public: 04042761031097
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 08YW-0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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: Hospitalization; Required Intervention