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

Model Number A22040A

Device Problems Break (1069); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2022

Event Type  Injury  

Event Description

The customer reported to olympus, during an unknown procedure, the inner sheath broke and fell into the patient.It is unknown if the piece was retrieved or if it remains in the patient.A request for additional information is in progress.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 14279971
• MDR Text Key: 293616631
• Report Number: 2951238-2022-00393
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2022,05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 185W-0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other