MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22040A

Device Problems Material Fragmentation (1261); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2022

Event Type  Injury  

Event Description

The customer reports during unspecified procedures using a 26fr.Resection sheath, the tip of the sheath broke inside the patient.The shards fell inside the patient, but the physician was able to retrieve all the shards.After the issue, the physician was able to complete the procedure with a similar item without any further issues.This has occurred on three occasions.Case with patient identifier: (b)(6) reports occurrence 1 of 3, case with patient identifier: (b)(6) reports occurrence 2 of 3, case with patient identifier: (b)(6) reports occurrence 3 of 3.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 15932645
• MDR Text Key: 304999281
• Report Number: 2429304-2022-00154
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2022,12/07/2022

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: 21301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other