MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NO NEW INFORMATION WAS PROVIDED

Model Number 37370DL

Device Problem Material Separation (1562)

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

Event Type  Injury  

Event Description

The event occurred in china: it was reported that the hook was broken during surgery.The broken part fell into the patient's body but could successfully be retrieved.No harm to patient, user or third reported.Internal karl storz reference number: (b)(4).

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.

Event Description

There is no new information provided for this field.

Manufacturer Narrative

The article 37370dl was probably subjected to too much force, which caused the hook to break at the distal end.Since the rest of the hook is still in the instrument and the weld is not damaged, a possible cause is that the hook was overloaded, causing it to bend and beyond which led to the breakage.By reviewing the similar complaint there is no indication for an increase/ trend of the reported issue.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

This supplimental report is to correct the the date in section b4 to refelct the accurate date in which the first supplimental report was submitted on (b)(6) 2023.Internal karl storz reference number: (b)(6).

Event Description

No new information was provided.

• Brand Name: NO NEW INFORMATION WAS PROVIDED
• Type of Device: NO NEW INFORMATION WAS PROVIDED
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 15735365
• MDR Text Key: 303079459
• Report Number: 2020550-2022-00300
• Device Sequence Number: 1
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022,01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37370DL
• Device Catalogue Number: 37370DL
• Device Lot Number: YO02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention