MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, 5 FR.

Model Number 26160SHW

Device Problems Crack (1135); Material Fragmentation (1261); Pitted (1460)

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

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id:(b)(4).

Event Description

It was reported that fragment was identified in the uterus when viewed on the monitor during the cervical procedure with the 26160shw(zp02).The procedure was delayed to identify and remove the debris; however, the debris was very fine and could not be removed.There has been no impact on the patient so far.

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

The claimed item 26160 shw with the date of manufacture december 2020 was found to be damaged at the distal end.The article has cracks in the material and a notch in the fork.A check of the inspection lot shows that no defects were found during the inspection.The initial stage of pitting and the notch developing into a crack.The piece missing from the notch is less than a millimetre in size, which may indicate that this piece has rusted away due to corrosion (as pitting can be seen at the edges), or it may have come loose during surgery.Therefore, as described in the instructions for use the item should be checked for function and damage before each use.Otherwise, pieces may come loose due to damage or, as in this case, corrosion.Internal karl storz reference number: (b)(4).

• Brand Name: SCISSORS, 5 FR.
• Type of Device: SCISSORS, 5 FR.
• 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: 17326738
• MDR Text Key: 319189281
• Report Number: 9610617-2023-00159
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551094655
• UDI-Public: 4048551094655
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

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: 26160SHW
• Device Catalogue Number: 26160SHW
• Device Lot Number: ZP02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/25/2023; 10/11/2023
• Supplement Dates FDA Received: 08/10/2023; 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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