MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER TUBE FOR 26050SL; RESECTOSCOPE INNER TUBE

Model Number 26050XA

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

No device evaluation is available at this time.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): following information is per facility's description of the event: during resection of a fibroid, the ceramic tip of the resector broke off and remained in the uterus.The doctor succeeded in recovering 2 fragments but we cannot say that there is no micro-fragment left that is invisible in endoscopy (hysteroscopy).It was necessary to increase the dilatation of the cervix to recover the broken part.Moreover, we had reached the maximum number of re-injection pockets allowed during a hysteroscopy, so the procedure could not be finished and the patient will probably have to be taken back to the or.No clinical consequences noted at this time.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

Manufacturer Narrative

"during resection of a fibroid, the ceramic tip of the resector broke off and remained in the uterus.The doctor succeeded in recovering 2 fragments but we cannot say that there is no micro-fragment left that is invisible in endoscopy (hysteroscopy).It was necessary to increase the dilatation of the cervix to recover the broken part.Moreover, we had reached the maximum number of re-injection pockets allowed during a hysteroscopy, so the procedure could not be finished and the patient will probably have to be taken back to the or no clinical consequences noted at this time".

• Brand Name: INNER TUBE FOR 26050SL
• Type of Device: RESECTOSCOPE INNER TUBE
• 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: 10432036
• MDR Text Key: 204592073
• Report Number: 9610617-2020-00090
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551092668
• UDI-Public: 4048551092668
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K882270
• 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,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26050XA
• Device Catalogue Number: 26050XA
• Device Lot Number: TY01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2011
• 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
• Patient Outcome(s): Other
• Patient Sex: Female