MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SPARE LOOP FOR SUPRALOOP

Model Number 26183MD

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the customer used three loops in row with the same lot un05, but they broke.After that when they used a loop with a different lot, it worked correctly.Unfortunately, our customer threw the damaged loops away.We would like to ask you to check these loops with this lot and exchange it for loops from different batches.It was later revealed that all loops were damaged during use in patient in a row.Everything was recovered from the patient.Yes, malfunction of the loops extend the d procedure for period of exchanging of these three loops.There was no harm caused to the patient and no extension of hospitalization was needed.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Due to an error during the review of the initial complaint, the initial report is deemed not reportable after re-evaluation.There was no adverse event or malfunction related to this event.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SPARE LOOP FOR SUPRALOOP
• Type of Device: SPARE LOOP
• 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: 17032368
• MDR Text Key: 316692037
• Report Number: 9610617-2023-00115
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: K944793
• 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,Followup
• Report Date: 07/06/2023

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: 26183MD
• Device Catalogue Number: 26183MD
• Device Lot Number: UN05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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