MAUDE Adverse Event Report: KARL STORZ SE & CO. KG URETERO-RENO-FIBERSCOPE FLEX-X2S

Model Number 11278A1

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.The complaint is based on a misunderstanding.The customer assumed that the repair/exchange process provides that he will receive a new endoscope (i.E.A newly produced one and not one from the second-hand stock).He was therefore surprised to receive a device with the same serial number as the one he had previously sent in for repair.In fact, in case of repair, the customer will receive a similar/repaired one from the second-hand stock.In this case, the customer did receive the same serial number as an exchange; however, the repair process and the final inspection ensured that the customer received a refurbished and inspected device.Thus, a product related malfunction or a logistics issue could be excluded.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was event with a uretero-reno-fiberskop.The following information was provided: after receiving a flexible endoscope back it was noticed that the serial number of an old exchanged scope was on this new replacement ureterorenoscope.Possible traceability issue.No patient involvement.No functional problem.

• Brand Name: URETERO-RENO-FIBERSCOPE FLEX-X2S
• Type of Device: URETERO-RENO-FIBERSCOPE FLEX-X2S
• 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
• MDR Report Key: 17118488
• MDR Text Key: 317065898
• Report Number: 9610617-2023-00675
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K982905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2023

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: 11278A1
• Device Catalogue Number: 11278A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2018
• 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