MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

Model Number A42011A

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The customer reported that his olympus resection sheath had button damage and a loose ceramic tip.According to the initial reporter, this event had no patient/procedure involvement.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.The ceramic tip was found damaged.Additionally, the black cap was missing and both the spring housing as well as the sealing ring were damaged.If additional information becomes available following the device evaluation, a supplemental report will be filed.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: SHEATH
• 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: 18148334
• MDR Text Key: 328278683
• Report Number: 9610773-2023-03315
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Lot Number: 108W-0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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