MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 70°, 4 MM; OLYMPUS HYSTERORESECTOSCOPE

Model Number A22003A

Device Problem Crack (1135)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation (cracked components) was confirmed.Dents on the distal edge and a broken meniscus ( loose objective window) were observed.In addition there were scratches on the outer tube and a blurry image due damaged (scratches) optical fibers.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported that a telescope, 70°, 4 mm had cracked components.The event occurred during reprocessing.There was no patient harm associated with the event.

• Brand Name: TELESCOPE, 70°, 4 MM
• Type of Device: OLYMPUS HYSTERORESECTOSCOPE
• 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: 17547268
• MDR Text Key: 321150301
• Report Number: 9610773-2023-02237
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020862
• UDI-Public: 04042761020862
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2023

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
• Device Operator: Health Professional
• Device Model Number: A22003A
• Device Lot Number: 707939A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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