MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STANDARD COLONOSCOPE 3.8/1600 PAL

Model Number 13925PKS

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Related evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.The customer complaint could be confirmed.The actual cause of the crack in the ropes in/on the control mechanism cannot be named with absolute certainty, as a material defect in the wire rope hoists or pre-damage during damage during assembly cannot be ruled out.However, it is certain that the installed wire rope hoists show considerable detachment of the coating in the shaft and distal area.These detachments lead to an increased coefficient of friction within the rope pull guides and in the flexible angular range, which results in significantly increased force during use in the form of significantly increased force required for control.This means that the increased force can lead to a crack in the rope.The problem was addressed within capa19-0003.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that a cable on colonoscope 13925pksk broke.Surgery delay >5 minutes.No further information available.

• Brand Name: STANDARD COLONOSCOPE 3.8/1600 PAL
• Type of Device: STANDARD COLONOSCOPE 3.8/1600 PAL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17031023
• MDR Text Key: 316692242
• Report Number: 9610617-2023-00662
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13925PKS
• Device Catalogue Number: 13925PKS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• 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