MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 22FR

Model Number 27026B

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by the hospital that the device will not be available for investigation, therefore no physical investigation on the device can be executed.The analysis of complaint data showed that former reported cases with similar failure description were deemed as caused by overloading and application of leverage forces.As the current device was manufactured in 2003, pre-damages cannot be excluded.Furthermore, the information was received that the device was sent to a third party for repair.It cannot be excluded that damages or improper repairs were done on the device.

Event Description

As per a manufacture incident report we received from the factory in (b)(6), which was filed with the (b)(6): the patient was treated as an emergency with a urinary stasis kidney on (b)(6) 2020 at about 0:30.During the endoscopic procedure with the said cystoscope shaft, the attending physician suddenly found the tip of the instrument in the bladder.The instruments were changed and the tip was tried to be recovered.The recovery was unsuccessful and led to a prolongation of the procedure by about 15 minutes.The patient was informed about the whereabouts of the tip and a new operation was planned for the same day.Around noon on (b)(6) the patient was treated personally by the doctor.With the use of a dormiah basket and pliers, the tip was removed from the bladder.The procedure lasted about 15 minutes without anesthesia.The bladder mucosa and the ostia were inconspicuous to the doctor during the second operation.Therefore, doctor does not expect any immediate health damage, except for the necessity of an endoscopic second intervention without anaesthesia and an extended anaesthesia of about 15 min for the first intervention.

• Brand Name: CYSTOSCOPE SHEATH, 22FR
• Type of Device: CYSTOSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10341060
• MDR Text Key: 204755673
• Report Number: 9610617-2020-00088
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2020

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: 27026B
• Device Catalogue Number: 27026B
• Device Lot Number: HG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2003
• 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): Required Intervention