MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, BLUNT, 5 FR., 34 CM

Model Number 26159EHW

Device Problems Crack (1135); Material Fragmentation (1261); Use of Device Problem (1670)

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

Event Date 07/10/2023

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

Tiny metal fragments (powder-like) were dislodged from the scissors when it was inserted into the patient's uterus via single-flow operating sheath.One larger fragment attempted to be removed but washed out when trying to transfer to the specimen container.

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

Visual and microscopical examination revealed that the cutting surfaces show the usual signs of wear considering their age (manufacturing date - august 2018).A closer inspection of the blades does not reveal any defects.The function of the blades was tested and is given.Since the article is already from 2018, defects / product issues on the cutting blades would have been noticed earlier.It cannot be confirmed that the foreign particles are material from the shears.The ifu refers to the service life of the product and regular testing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SCISSORS, BLUNT, 5 FR., 34 CM
• Type of Device: SCISSORS, BLUNT
• 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: 17491417
• MDR Text Key: 320710300
• Report Number: 9610617-2023-00206
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551094280
• UDI-Public: 4048551094280
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K935071
• 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: 11/17/2023

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: 26159EHW
• Device Catalogue Number: 26159EHW
• Device Lot Number: VR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/09/2023; 10/20/2023
• Supplement Dates FDA Received: 08/22/2023; 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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