MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL

Model Number 27050XA

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.Attempts were made to obtain the reported device for evaluation; however, device has not been returned at the time of this report.If the reported device would be returned for evaluation in the future, a supplemental report would be made.The reported issue will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the piece(s) at the tip of the sheath came off.The hospital realized the piece(s) came off after the surgery at the end of the day.The device was utilized for rtu surgery, but it was unknown when the piece(s) came off.The piece(s) could not be found.There was no report of injury to the patient and the patient was informed of the incident.X-rays were performed on patient to attempt to locate the piece(s); however, the finding was still pending investigation by the hospital.

• Brand Name: INNER SHEATH FOR 27050 SL
• Type of Device: INNER SHEATH FOR 27050 SL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave.; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17671371
• MDR Text Key: 322518951
• Report Number: 9610617-2023-00219
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/01/2023

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: Health Professional
• Device Model Number: 27050XA
• Device Catalogue Number: 27050XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 09/01/2023
• 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: Unknown
• Patient Sequence Number: 1