MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 13 FR.; ENDOSCOPE SHEATH, REUSABLE

Model Number 27032L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Discomfort (2330)

Event Date 08/18/2023

Event Type  Injury  

Event Description

It was reported that the tip of 27032l broke off in patient.This was not discovered until patient presented back to hospital with pain on 1st of september.Scan performed where tip of sheath was found in patient.Medical intervention performed and damaged tip removed.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CYSTOSCOPE SHEATH, 13 FR.
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17869965
• MDR Text Key: 324910484
• Report Number: 2020550-2023-00273
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551232231
• UDI-Public: 4048551232231
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2023,10/04/2023

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: 27032L
• Device Catalogue Number: 27032L
• Device Lot Number: MG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male