MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 26 FR.

Model Number 26040JB1

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2020

Event Type  Injury  

Event Description

It was reported that there was event with a cutting loop, bipolar, 26 fr.According to the information received that during resection, cutting loop broke and felt in uterus.It seems that a small piece remained in uterus.Information about patients health was not provided.Additional patient information is not available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.No product was returned.Therefore, no physical investigation can be executed.The complaint records have been analyzed for similar cases.No similar failure description was found.No indications for a systematic issue.Date of manufature not known.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 26 FR.
• Type of Device: CUTTING LOOP, BIPOLAR, 26 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen
• 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: 17210122
• MDR Text Key: 317982772
• Report Number: 9610617-2023-00857
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26040JB1
• Device Catalogue Number: 26040JB1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 06/27/2023
• 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