MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 330 MM, GRASPING FORCEPS, FENESTRATED; BIPOLAR GRASPING FORCEPS

Model Number WA64120C

Device Problem Defective Component (2292)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The customer reported that when using a jaws "hiq+", bipolar, 5 x 330 mm, grasping forceps, fenestrated, the forceps was broken, and the insulation was incomplete.The event occurred during preparation for use.The therapeutic laparoscopic procedure was completed with a similar device.There was no procedural delay, or no patient harm associated with the event.

Manufacturer Narrative

The device will not be returned for evaluation as it was suggested to dispose of the device since it cannot be repaired.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

Updated fields: h6, h10.Corrected fields: d8/d9/h6 (3rd party repair).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned to olympus, but was inspected by a third party and the reported events were confirmed.The device history record was unable to be reviewed for this device and the manufacturer date is unavailable since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause could not be determined.It is likely the damaged mechanism occurred due improper handling and the incomplete insulation was likely caused by unauthorized repairs by a third-party.Olympus does not recommend repair actions by unauthorized service centers.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, GRASPING FORCEPS, FENESTRATED
• Type of Device: BIPOLAR GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17625005
• MDR Text Key: 321977876
• Report Number: 9610773-2023-02352
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761062411
• UDI-Public: 04042761062411
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K984417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA64120C
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• 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