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

Model Number 27050XA

Device Problems Component Falling (1105); Crack (1135); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been returned for evaluation.The device is approximately 3 years old; the most likely cause of this type of breakage is mechanical force.

Event Description

Allegedly, during an intra-uterine fibroid resection procedure, the tip of inner tube cracked and pieces broke off into the patient.Doctor was able to retrieve the pieces and confirmed there was no patient impact.

Manufacturer Narrative

Supplemental report filed to correct the event date from (b)(6) 2018 to (b)(6) 2018.

Manufacturer Narrative

We evaluated the returned device and found the ceramic beak is broken off from the distal end of inner tube and there are what appears to be tool marks on the distal end of the shaft.Damage is most likely due to the ceramic beak making contact with a hard surface causing an internal crack and resulting in breakage; we cannot confirm.

• 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
• MDR Report Key: 7631898
• MDR Text Key: 112289291
• Report Number: 9610617-2018-00042
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551078136
• UDI-Public: 4048551078136
• Combination Product (y/n): N
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

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: Physician
• Device Model Number: 27050XA
• Device Catalogue Number: 27050XA
• Device Lot Number: TU10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 06/01/2018; 06/01/2018
• Supplement Dates FDA Received: 07/05/2018; 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other