MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CANNULA SUCTION & COAGULATION

Model Number 37370DL

Device Problem Material Separation (1562)

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

Event Type  Injury  

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

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 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 supplemental report is to correct the date in section b4 to reflect the accurate date in which the first supplemental report was submitted on january 5, 2023.Internal karl storz reference number: (b)(4).

• Brand Name: CANNULA SUCTION & COAGULATION
• Type of Device: CANNULA SUCTION & COAGULATION
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15735415
• MDR Text Key: 304038124
• Report Number: 9610617-2022-00300
• Device Sequence Number: 1
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K944862
• 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,Followup
• Report Date: 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?: Yes
• 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
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1