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

Model Number	26050XA
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device evaluation is available at this time.
Event or Problem 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.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.
Additional 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
• Common Device Name: 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
• Report Number: 9610617-2020-00090
• Device Sequence Number: 11581635
• Product Code: HIH
• UDI-Device Identifier: 04048551092668
• UDI-Public: 4048551092668
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: 26050XA
• Device Catalogue Number: 26050XA
• Device Lot Number: TY01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 07/31/2020; 08/11/2022
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 08/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female