MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE INSULATED OUTER TUBE

Model Number	33300W
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was evaluated by the manufacturer, karl storz in (b)(4).Per their evaluation, "the bayonett deformed and the insulation of the sheath damaged (cuts and scratches) all over the length.The deformation of the bayonett pre-damaged the bayonett wing and lead to the final break.The damages in the insulation would have been justification enough to take this part out of service long ago, as the insulation capability is corrupted and proper cleaning is not possible anymore.This is clearly given in ifu on page 1, 5 safety instructions, second warning, and page 2 seventh warning.Special this would have led to detect the damage straight after the procedure and prevented the patient from injury.The device in question has been in service for near 12 years.".
Event or Problem Description
We received a vigilance report from our manufacturer in (b)(6) which was filed with the national competent authority, (b)(6) in (b)(6).Allegedly, a female patient underwent a lap chole procedure on (b)(6) 2018.A month after the procedure, the patient complained about abdominal pain in the operated region.A subsequent ct scan showed a 4mm metal fragment situated below the umbilicus.A second procedure to remove the fragment was performed on (b)(6) 2018.

• Brand Name: CLICKLINE INSULATED OUTER TUBE
• Common Device Name: OUTER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8276481
• Report Number: 9610617-2019-00015
• Device Sequence Number: 167792
• Product Code: GCJ
• UDI-Device Identifier: 04048551133972
• UDI-Public: 4048551133972
• Combination Product (Y/N): N
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 33300W
• Device Catalogue Number: 33300W
• Device Lot Number: CD592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention