MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	170056
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Emotional Changes (1831); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Burning Sensation (2146); Distress (2329); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a total laparoscopic hysterectomy, the needle broke.It was noted that half of the needle was left in the patient cavity and was not retrieved.An x-ray was performed to locate the needle.Product was received without accompanying information.
Additional Manufacturer Narrative
D10 concomitant products: 173016, 173016 endo stitch instrument (lot# j2l1928ey) 173016, 173016 endo stitch instrument (lot# j2k0014ey) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Pli:10 the product was used for a total laparoscopic hysterectomy.During the surgery the devices suturing needle broke in half and it was unable to be retrieved, to date, the piece of broken needle still remains inside the patient.It was reported that after usage of the device the patient experience, bleeding, burning pain, chronic pelvic pain, device defective, pain, suffering, loss of quality of life, mental anguish, emotional distress.Post-operative patient treatment included x-ray.

• Brand Name: POLYSORB
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112 ; 8006464633
• MDR Report Key: 20196246
• Report Number: 9612501-2024-02292
• Device Sequence Number: 7649626
• Product Code: OCW
• UDI-Device Identifier: 20884521126579
• UDI-Public: (01)20884521126579(17)290131(10)J4B3222Y(20)01
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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
• Operator of Device: Health Professional
• Device Model Number: 170056
• Device Catalogue Number: 170056
• Device Lot Number: J4B3222Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 02/16/2024
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 38 YR
• Patient Sex: Female