MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SC; SHEATH FOR RIGID ENDOSCOPE

Model Number 27050CA

Device Problem Break (1069)

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

Event Date 12/06/2022

Event Type  Injury  

Event Description

Initially received information: planned procedure: prostate laser enucleation.Problems encountered: the broken inner sheath of the resector scope remained in the bladder.Enucleation procedure without difficulty.The inner sheath may have presented a problem at the beginning of the procedure because the back light source seemed to be slightly deflected in rotation.No problem to note until the removal of the resector before morcellation.Upon removal of the resector scope, the absence of the back light was noted.Examination of the resector scope shows that the inner sheath is in fact broken along almost its entire length downstream of the zone of attachment to the outer sheath.It is impossible to remove this sheath endoscopically with forceps because the end is very sharp and there is a risk of damaging the urethra.Therefore, a conversion with a mini bladder size is decided.Endoscopy completed in laparoscopy.The patient is fine.Further information received: a bladder incision had to be made when the procedure was natural.The procedure was extended by one hour.No additional hospitalization was necessary.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

The shaft is broken in the rear area at the holes.In addition, there are signs of use corresponding to age.The article was already produced in 2016 and used accordingly often.On the shaft can be seen that the original labeling was taped off and the shaft was reworked, so it can be assumed that this was a third-party repair.It cannot be determined which other repairs were carried out.The root cause is most probably user related.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SC
• Type of Device: SHEATH FOR RIGID ENDOSCOPE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16038136
• MDR Text Key: 306070749
• Report Number: 9610617-2022-00340
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K943668
• 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: 02/17/2023

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: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: ST01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization