MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS RIGID LAPAROSCOPE; 0 DEGREE,5MM,29CM

Model Number 26046AA

Device Problems Break (1069); Optical Distortion (3000)

Patient Problems Liver Laceration(s) (1955); Renal Impairment (4499)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is on-going.Product has not been returned for evaluation.Photographs of telescope provided with letter from reporting law firm depict damage/dent to the exterior of the telescope, which is likely related to user handling, care, and maintenance of the telescope.Should the product be returned for evaluation that provides additional information/investigation results, a supplemental medwatch will be submitted.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported to the company through a letter from a law firm that there was event with an 26046aa hopkins telescope 0 degree,5mm, 29cm.According to the operative report as quoted in the letter: "pt underwent laparoscopic cholecystectomy with intraoperative cholangiogram.Using a direct view technique with the laparoscope in the 5mm trocar we inserted a 5mm laparoscopic port.It was at this point in time when we realized that the laparoscope was broken and we had extremely poor visual quality.A liver injury was identified with significant bleeding.We then obtained a new 5mm 0 degree laparoscope and upsized the existing port to a 12 mm port in the lateral clavicular line." the event description in the letter's incident report from the physician notes: "protocol was not followed and faulty/broken surgical equipment was used.This caused a significant adverse patient outcome.Liver injury with approx.1 l blood loss, prolonged surgical time, transfusion of prbc and transfer to higher lever of care." investigation is ongoing.Product was requested but not yet received.The matter has been referred to legal.

Manufacturer Narrative

According to the information provided, a damaged and vision-impaired optic was used on the patient, which resulted in tissue trauma.According to the data, damaged rod lenses and several damages on the shaft were found, the ifu explicitly states in points that damaged products should not be used, as the damage may result in injury.The user acted contrary to the stated instructions in the user manual.The ifu safety instructions notes to observe and follow the instruction manual to avoid risk of injury to the patient.Percautions in the ifu state telescopes must always be held by the eyepiece and never the distal end alone and not to bend the sheath in any circumstance.A more detailed examination of the optics could not be carried out, as the optics were not returned for examination.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: HOPKINS RIGID LAPAROSCOPE
• Type of Device: 0 DEGREE,5MM,29CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA ; 4242188247
• MDR Report Key: 16919634
• MDR Text Key: 315097978
• Report Number: 9610617-2023-00097
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26046AA
• Device Catalogue Number: 26046AA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White