MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.

Model Number A22041A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The resection sheath was returned to olympus for evaluation.The evaluation confirmed that the black tip on the resection sheath was broken off.Based on the visual inspection performed the beak (tip) was found to have deep scratch on its body, and uneven jagged edges.The remaining portion of the beak is still glued inside the inner sheath; there was no missing fragments noted.There is evidence of adhesive remnants between the inner sheath and the beak, which is indicative that the beak had been glued properly.The jagged edges of the broken ceramic beak are attributed to excessive force being applied on the resection sheath or indicative that the resection sheath was hit or dropped during use.The instructions for use provides a warning note which states that "impact, fall, shock or similar stress can damage the ceramic insulation at the sheath's distal end and that the instrument must not be used if damaged since otherwise this can cause injuries to the patient and/or user." in addition, the oem performed a manufacturing and quality control review for the affected lot number without showing any non-conformities or deviations regarding the related issue.

Event Description

Olympus was informed that during a bipolar resection procedure, the black plastic tip on the end of the sheath broke off inside the patient.The device fragment was retrieved without injury to the patient.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH, 24 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8405531
• MDR Text Key: 141329229
• Report Number: 2951238-2019-00525
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2019

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: No Information
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 124W-0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No
• 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