MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, 26 FR.; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, M

Model Number 26050G

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

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 6.The event is filed under internal karl storz complaint id (b)(4).No investigation possible, no product returned.No information on affected lot code.According to the email received on 9th april 2020 the product was discarded.Complaint data was analyzed, no indication for a systematic issue.Not possible to identify a root cause as no investigation possible.Device was not returned and no further information was received, therefore the case is considered as closed.If further information will be available the case will be reopened and reevaluated.

Event Description

It was reported that there was event with a "cutting loop".According to the information received, a piece (1-2mm) of cutting loop (26050g) fell inside the body and lost.The hospital tried to find it using x-ray (c-arm), but could not find the piece.Further information is not available.

• Brand Name: CUTTING LOOP, 26 FR.
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, M
• 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: 17435851
• MDR Text Key: 320173911
• Report Number: 9610617-2023-00829
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26050G
• Device Catalogue Number: 26050G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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