MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL; RESECTOSCOPE SHEATHS ARE INTENDED FOR CREATION OF AN ACCESS AND WORKING/IRRIGATI

Model Number 27040XA

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2023

Event Type  Injury  

Event Description

It was reported that at end of a procedure, the surgeon moved to use a ball electrode, and noticed the ceramic tip had detached inside the patient and via endoscopic view.Tried to retrieve via several attempts with biopsy forceps but was unable to do so due to swollen tissue occluding vision and anesthetic exposure time.The patient is due to return in 3 weeks' time, surgeon intends to use a stone crusher on the detached part.

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: INNER SHEATH, FOR 27040 SD/SL
• Type of Device: RESECTOSCOPE SHEATHS ARE INTENDED FOR CREATION OF AN ACCESS AND WORKING/IRRIGATI
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16566629
• MDR Text Key: 311513451
• Report Number: 2020550-2023-00056
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/15/2023,03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: OT08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2023
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention