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

Model Number 13925NKS

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.During the investigation, it was found that the endoscope doesn't show any damage or sharp edge in the vertebrae aerea at all.There is no indication for a product problem / manufacturing failure.The injuries are most likel caused by lack of space and too high pressure on the mucosal skin in the colon.The event is filed under internal karl storz complaint id (b)(6).

Event Description

It was reported that it came to bleeding with 6 different patients in different sections of the examination procedure.No further information regarding the patient outcome provided.

• Brand Name: STANDARD COLONOSCOPE 3.8/1600 NTSC
• Type of Device: STANDARD COLONOSCOPE 3.8/1600 NTSC
• 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: 17031012
• MDR Text Key: 316381319
• Report Number: 9610617-2023-00664
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13925NKS
• Device Catalogue Number: 13925NKS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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