MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN ENDO STITCH INSTRUMENT; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number UNKNOWN ESTITCH

Device Problems Break (1069); Detachment of Device or Device Component (2907); Mechanics Altered (2984)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Fatigue (1849); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Depression (2361); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Fibrosis (3167); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

According to the reporter, intraoperatively, the handle was introduced and closure of the vagina was initiated using vloc suture.After the second throw, the needle was broken, with half of the needle still on the handle and the half presumably in the tissue of the vaginal cuff.A careful inspection was performed both from above and vaginally in an attempt to identify the broken needle half without disturbing the previously cauterized collateral vessels.Intra-operative radiograph was also performed.The needle in half was not identified.The decision was made to proceed with closure, as the risk of opening was deemed greater than the risk of leaving the needle piece in situ.

Manufacturer Narrative

Concomitant medical products: vloca008l v-loc* 180 0 abs reload 20cm (lot: n2c0683y).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the laparoscopic hysterectomy, bilateral salpingectomy with cystoscopy, the handle was introduced and closure of the vagina was initiated using vloc suture.After the second throw, the needle was broken, with half of the needle still on the handle and the half presumably in the tissue of the vaginal cuff.A careful inspection was performed both from above and vaginally in an attempt to identify the broken needle half without disturbing the previously cauterized collateral vessels.Intra-operative radiograph was also performed.The needle in half was not identified.The decision was made to proceed with closure, as the risk of opening was deemed greater than the risk of leaving the needle piece in situ.

Manufacturer Narrative

Additional info: a1, a2, a3, a4, b5, b6, b7, d4 (model #), e1, e3, h6 (all codes) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of total laparoscopic hysterectomy (tlh) and cystoscopy.According to the reporter, the vloc needle portion of the endostitch broke off with half of the needle still on the handle and the half presumably in the tissue of the vaginal cuff.A careful inspection was performed both from above and vaginally in an attempt to identify the broken needle half without disturbing the previously cauterized collateral vessels.Intra-operative radiograph was also performed.The needle in half was identified.The decision was made to proceed with closure, as the risk of opening was deemed greater than the risk of leaving the needle piece in situ.The patient suffered injuries, free air, inflammation, abdominal pain, feeling of pressure, pain, shoulder pain, anxiety, fatigued, spotting, back pain, vaginal bleeding, adhesions, fibrotic tissue, and continues to suffer effects from the procedure.Treatment included reoperation to remove the retain ed needle, medications, iv fluids, diagnostic laparoscopy, x-ray, ct scan, vaginal cuff revision, lysis of adhesions, bilateral ureterolysis, excision of endometriosis, and cystoscopy.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional info: a1, a2, a5a, a5b, b5, h6 (patient codes, device codes) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of total laparoscopic hysterectomy (tlh) and cystoscopy.According to the reporter, the vloc needle portion of the endostitch broke off with half of the needle still on the handle and the half presumably in the tissue of the vaginal cuff.A careful inspection was performed both from above and vaginally in an attempt to identify the broken needle half without disturbing the previously cauterized collateral vessels.Intra-operative radiograph was also performed.The needle in half was identified.The decision was made to proceed with closure, as the risk of opening was deemed greater than the risk of leaving the needle piece in situ.It was reported that after the surgery, the patient experienced injuries, free air, inflammation, abdominal pain, feeling of pressure, pain, shoulder pain, anxiety, fatigued, spotting, back pain, vaginal bleeding, adhesions, fibrotic tissue, suffering, discomfort, cramping, achy, difficulty walking, deteriorating mental health, dysphoric mood, sleep disturbances, nervousness, depression, mental pain, emotional distress, bleeding, permanent disfigurement, device failure.Post-operative patient treatment included removal of the retained needle, medications, iv fluids, diagnostic laparoscopy, x-ray, ct scan, vaginal cuff revision, lysis of adhesions, bilateral ureterolysis, excision of endometriosis, cystoscopy, laparoscopic excision of retained needle with fluoroscopy.

• Brand Name: UNKNOWN ENDO STITCH INSTRUMENT
• Type of Device: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15837978
• MDR Text Key: 307502525
• Report Number: 9612501-2022-02047
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ESTITCH
• Device Catalogue Number: UNKNOWN ESTITCH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NOTE ON H10
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White