MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 26053SC, 15FR; RESECTOSCOPE INNER SHEATH TUBE

Model Number	26053CB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is in transit to the factory.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): as reported: "during a hysteroscopy resection of a polyp, after a few minutes of intervention, there was an intrauterine spark between the shirt and handle.Observed breakage of the handle resection, and ceramic protection (bakelite shirt), burn of the optic.Gesture was arrested immediately.Fragments of the handle and the sleeve remained intrauterine without the possibility of removing them".
Additional Manufacturer Narrative
The following items were returned for evaluation: 26053cb / inner sheath f.Resect.Sheath, 15 fr.26120aa / hopkins telescope 0°, 2,9 mm, 30 cm.26053sc / resectoscope sheath, 15fr.During the examination of the returned articles 26053cb, 26053sc, and 26120aa, the following was found: article 26120aa: has a burn at the distal end.The ifu contains a risk of injury warning due to incorrectly assembled and damaged instruments.The ifu points out that failure to comply with this instruction manual and all instructions for use of the products used in combination, or incorrectly assembled and damaged instruments, can lead to injuries to the patient.Article 26053cb: the ceramic beak is damaged or broken.On the ceramic that remains inside the shaft, slight black smack marks can be seen.The ifu contains warnings regarding risk of injury due to overloading, that the sheaths with ceramic tip must be handled carefully and must be checked for cracks or other damage before each use, and that damaged sheaths (chipped or cracked) must never be used since malfunctions could occur, which could lead to patient injury.Conclussion: one must assume that here a mistake has been made in the assembly of the individual components by the user.The assembly for one application consists of the components inner sheath ( 26053cb), resectoscope sheath (26053sc), working element ( 26053eb), optics (26120aa) and a sling / electrode (011010-01).The assembly of these components is described in the instructions for use.Since these have probably not been adhered to properly, the sling was slightly bent during assembly.As a result, the position of the sling to the optics has changed slightly.This allowed a smaller distance or a touch of sling and optics whereby there was a short circuit or a spark strike that damaged the optics at the distal end.As a result, the smack marks on the shaft interior of article 26053cb are most likely created.The ceramic damage was caused by mechanical impact or levering.Manufacturing defect or transport damage can be ruled out due to delivery in 2020.
Event or Problem Description
During a hysteroscopy resection of a polyp, after a few minutes of intervention, it there was an intrauterine spark between the shirt and handle.Observed breakage of the handle resection, and ceramic protection (bakelite shirt), burn of the optic.Gesture was arrested immediately.Fragments of the handle and the sleeve remained intrauterine without the possibility of removing them.The patient has been warned.Generator settings irrigation and resection are classic and used for each intervention of the same type no immediate consequences but risk long-term potential (traumatic? infectious?) since the pieces of ceramic of the shirt as well as the metal end of the handle could not be found.

• Brand Name: INNER SHEATH FOR 26053SC, 15FR
• Common Device Name: RESECTOSCOPE INNER SHEATH TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 12008990
• Report Number: 9610617-2021-00050
• Device Sequence Number: 11619502
• Product Code: HIH
• UDI-Device Identifier: 04048551410479
• UDI-Public: 4048551410479
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 26053CB
• Device Catalogue Number: 26053CB
• Device Lot Number: YP01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other