MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER TUBE WITH CERAMIC BEAK; RESECTOSCOPE SHEATH INNER TUBE

Model Number 27050XA

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been returned for evaluation.The most likely cause of this type of breakage is mechanical force.

Event Description

Allegedly, during a hysteroscopic myomectomy procedure, the tip of the resectoscope inner tube broke into multiple pieces intra-uterine.They were able to remove all pieces except for one piece approximately one millimeter in size, which they believe was most likely flushed out during the procedure.

• Brand Name: INNER TUBE WITH CERAMIC BEAK
• Type of Device: RESECTOSCOPE SHEATH 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 90245-5017 ; 4242188201
• MDR Report Key: 8966441
• MDR Text Key: 156790800
• Report Number: 9610617-2019-00073
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551078136
• UDI-Public: 4048551078136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2019

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: 27050XA
• Device Catalogue Number: 27050XA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 YR
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 48 YR
• Patient Weight: 74