MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22041A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified therapeutic procedure a defective resectoscope was used and the patient consequently suffered a bleeding.The ceramic insulation of the resectoscope broke during assembling before surgery and due to a misunderstanding the defective device was used.No further information was provided and the patient's current condition is also unknown.

Manufacturer Narrative

Additional information: b5 - describe event or problem.

Event Description

Olympus was informed that during an unspecified therapeutic procedure a defective resectoscope was used and the patient consequently suffered a bleeding.The ceramic insulation of the resectoscope broke during assembling before surgery and due to a misunderstanding the defective device was used.The urethra started to bleed during insertion and removal, but there was no permanent injury.No further information was provided.

Manufacturer Narrative

Additional information: g2 - report source.Device evaluation: the suspect medical device was returned to the manufacturer for investigation/evaluation.The investigation confirmed that the ceramic insulation at the distal end of the resection sheath is broken off.This type of damage is typically caused by thermal and/or mechanical fatigue caused by wear and tear, possibly in combination with excessive force.Therefore, this event/incident was attributed to user error.It cannot be conclusively determined whether the insulating insert had been pre-damaged at some point in the past or whether the damage was triggered during the reprocessing cycle preceding the incident.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 14956148
• MDR Text Key: 295486025
• Report Number: 9610773-2022-00258
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2022

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: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 21812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 08/22/2022
• Supplement Dates FDA Received: 08/09/2022; 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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
• Patient Outcome(s): Required Intervention