MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RIGID ENDOSCOPE SHEATH

Model Number A22040A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 04/08/2024

Event Type  Injury  

Event Description

It was reported, the ceramic tip of the subject device broke during a therapeutic electrohysteroscopic surgery.The broken tip was removed from the patient and the device was replaced with another tube sheath.There was a delay of over 15 minutes and the procedure was completed thereafter.There were no reports of patient harm.

Manufacturer Narrative

E1 (documented here in its entirety due to character limitations in respective field) - establishment name: china welfare international peace maternity and child health center; address: no.910, hengshan road, xuhui district, shanghai; no.145, guangyuan chariot (family planning guidance center).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RIGID ENDOSCOPE 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, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19135234
• MDR Text Key: 340510865
• Report Number: 9610773-2024-01049
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Lot Number: 21919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2021
• 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
• Treatment: VIDEO SYSTEM CENTER (OTV-S300)
• Patient Outcome(s): Required Intervention
• Patient Sex: Female