MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, WAVE TYPE, MONOPOLAR

Model Number WA69334M

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2023

Event Type  malfunction  

Event Description

The customer reported that her olympus hicura jaws insert experienced an out of box failure.According to the initial reporter, the grasping forceps had misaligned jaws noted during the initial use of the device.There was no patient harm reported as a result of this event.

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, WAVE TYPE, MONOPOLAR
• Type of Device: JAWS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17765033
• MDR Text Key: 323638786
• Report Number: 9610773-2023-02614
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761079426
• UDI-Public: 04042761079426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA69334M
• Device Lot Number: 21603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1