MAUDE Adverse Event Report: LINA MEDICAL APS LINA BIPOLAR LOOP, LARGE

Model Number	BL-200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the day of initial report provided, the dhr documentation for product bl-200 batch 2310021 was reviewed and turned out that there is no deviation during assembly and manufacturing process which could have the impact of device malfunction.Information about incident we received on 23.09.2024 from lina's medical us which is the lina medical aps distributor (b)(4).In complaint form for this case stated that device is available for evaluation.
Event or Problem Description
Information which were provided to lina medical by us distributor: "product broke inside of pt, pieces recovered by surgeon." "all visible fragments were removed, cavity irrigated and aspirated.".
Event or Problem Description
Information which was provided to lina medical by us distributor: "product broke inside of pt, pieces recovered by surgeon"."all visible fragments were removed, cavity irrigated and aspirated".
Additional Manufacturer Narrative
The manufacturing documentation for product bl-200 2310021 was reviewed and no deviations were noted during the manufacturing and inspection processes.The component that broke was the fibre tube, the index before logo imprinting was r-0978 (after imprinting which is a process that takes place at lina medical from 2021 is h-1284).The r-0978 component has not changed since 2021.In addition, the batches of component r-0978 used in the production of the finished product (r-0978 220321-071 and 221125-17) were released without any non-conformities after incoming inspection.The ifu fv0137k for the lina bipolar loop product assumes inspection for defects, however, we received no information that the product had defects prior to use.The instructions recommend generator settings of 55-70 w (with a recommendation to use the lowest settings) the use of graspers and uterine manipulators to facilitate electrode placement around the uterine body or myoma is permitted.We were not informed what additional devices were used during the surgery.Furthermore, the hospital did not inform us about the sequence of events or the generator settings.The information obtained is very laconic and does not allow us to determine the cause of the event.The product was not returned for analysis.The hospital provided several photographs showing significant damage to the tube inside the abdominal cavity.We did not receive clear information on the patient's condition.We reviewed the risk analysis.As a result, we added the risks associated with tube damage.

• Brand Name: LINA BIPOLAR LOOP, LARGE
• Common Device Name: LINA BIPOLAR LOOP, LARGE
• Manufacturer (Section D): LINA MEDICAL APS; formervangen 5; glostrup, 2600 ; DA 2600
• Manufacturer (Section G): LINA MEDICAL; formervangen 5; glostrup, 2600 ; DA 2600
• Manufacturer Contact: agata lukaszewicz ; formervangen 5; glostrup, 2600 ; DA 2600
• MDR Report Key: 20492082
• Report Number: 3007699067-2024-00001
• Device Sequence Number: 19712702
• Product Code: HIN
• UDI-Device Identifier: 05708265004638
• UDI-Public: (01)05708265004638(17)260301(11)230302(10)2310021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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 Expiration Date: 03/01/2026
• Device Model Number: BL-200
• Device Catalogue Number: N/A
• Device Lot Number: 2310021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR LIGASURE SH31959.; GENERATOR LIGASURE SH31959.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female