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

Model Number 27032L

Device Problems Material Fragmentation (1261); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Discomfort (2330)

Event Date 08/18/2023

Event Type  Injury  

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).

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 complained products (27032l and 27032lo) were received at the manufacturing site 2023-09-26 and were therefore available for investigation.The investigation has been completed on the 2023-12-14.Findings: during the inspection of the claimed items 27032l and 27032lo, damage was only found on item 27032l.Here, the beak has become detached from the shaft at the distal end.It is also recognisable that a piece of material is missing from the beak.When checking the manufacturing date, it was noticed that the article is from december 2003.There is therefore a high probability that the item has reached the end of its life cycle due to years of reprocessing.The chemicals contained in the reprocessing process have probably washed out the braze connection between the beak and shaft over the 20 years.Therefore, before each use, the article should be checked for function and damage as described in the instruction for use.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to wear and tear in combination with a usage related failure.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
• 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: 17869968
• MDR Text Key: 324910510
• Report Number: 9610617-2023-00273
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551232231
• UDI-Public: 4048551232231
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male