MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TELESCOPE BRIDGE/WORKING INSERT

Model Number 28160GE

Device Problem Solder Joint Fracture (2324)

Patient Problem Brain Injury (2219)

Event Type  Injury  

Manufacturer Narrative

Device was recently returned to the manufacturer.Per their initial inspection: a broken weld joint on the endoscope locking mechanism was seen, and there are several spots of corrosion - very strong inside the endoscope locking mechanism.Part is from november 2006.

Event Description

As per a report we received from the factory in (b)(4) regarding an event that took place in (b)(6): handling difficult during operation; weld problem on the three-way stop cock.Damage to the left side of the brain postoperative.

• Brand Name: TELESCOPE BRIDGE/WORKING INSERT
• Type of Device: TELESCOPE BRIDGE
• 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: 10076824
• MDR Text Key: 191663936
• Report Number: 9610617-2020-00071
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 04048551234341
• UDI-Public: 4048551234341
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K982837
• 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
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28160GE
• Device Catalogue Number: 28160GE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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