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

Model Number WA64360C

Device Problems Loose or Intermittent Connection (1371); Output Problem (3005)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported, the root of the jaws was loose, and sparks appeared when output.The case was completed with the same set of equipment.There were no reports of patient harm.

Manufacturer Narrative

The device was returned.The evaluation found the insulation pad at the tip of the jaw was worn, and the insulation outer cover at the end was chipped.The wear of the insulation pad at the tip was caused by normal wear and tear during use, while the damage to the insulation outer cover at the end may be caused by the abrasion of the jaw core against the sleeve rod during installation or during cleaning and disinfection.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, DISSECTION FORCEPS, MARYLAND
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18788600
• MDR Text Key: 337075617
• Report Number: 9610773-2024-00542
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA64360C
• Device Lot Number: 23402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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