MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 430, CROCEOLMI, MONOPOLAR; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR (HANDLES, SHAFTS, JAWS INSERTS

Model Number	WA69320L
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Olympus was informed that during an unspecified procedure, one jaws distal end broke when taking and clamping the tissue and a fragment fell into the patient's body cavity.However, no fragment remained inside the patient since it was reportedly retrieved.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that one of the jaws at the distal end was broken off.Furthermore, the transmission wire guide which serves as an overload protection was found deformed and scratched.This is an indication of excessive and frequent use of the item.A prior damage of the item is possible.According to the product specification, the affected jaws insert is designed for 100 applications and reprocessing cycles which, considering the age and the signs of use of the device, have possibly been exceeded.Therefore, 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 jaws insert without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: JAWS INSERT "HICURA", 5 X 430, CROCEOLMI, MONOPOLAR
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR (HANDLES, SHAFTS, JAWS INSERTS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11997463
• Report Number: 9610773-2021-00164
• Device Sequence Number: 16418919
• Product Code: GEI
• UDI-Device Identifier: 04042761079280
• UDI-Public: 04042761079280
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K140624
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: WA69320L
• Device Catalogue Number: WA69320L
• Device Lot Number: 14XW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1