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

Model Number A22040A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The returned the a22040a lot# 18yw-0405 resection sheath was received for evaluation due to ¿tip came off/break off¿.The user¿s complaint was confirmed.Visual inspection was performed on the received condition and determined that approximately 90% percent of the ceramic beak from the distal end side was broken and missing the broken ceramic beak piece was not returned.There is an approximately 10% portion of the ceramic beak that is still intact on to the sheath from the distal end area.In addition, there are minor dents and scratches noted on the outer sheath of the device.Based on the results of the device evaluation, the cause of the reported complaint is due to mishandling.This event has been reported by the importer on mdr# 2951238-2020-00344.

Event Description

It was reported that the a22040a tip broke off and fell into the patient during a bladder evacuation procedure.The broken tip of the device was discovered after the procedure was completed when it was brought for reprocessing.Additional surgical and medical intervention was performed.The patient had to be brought back into surgery for a foreign body removal inside of the patient's bladder.The broken tip was successfully retrieved.According to the report, the patient is currently doing fine.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 9732815
• MDR Text Key: 194636892
• Report Number: 9610773-2020-00071
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931994
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• 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: 18YW-0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention