MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:10MM L:370MM; HANDHELD PRODUCTS & LIGATION

Model Number PL536R

Device Problem Fracture (1260)

Patient Problem Bowel Perforation (2668)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with pl536r - shaft compl.D:10mm l:370mm.According to the complaint description, the application of clips on a section of sleeve gastrectomy perforated the stomach.This was due to a "broken metal insertion of the clipper stem".An additional medical intervention was necessary.Sutures were applied to the perforation.Additional information was not provided nor available /was not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: d9 - product return.Investigation: until this time, no product was returned.Therefore, an investigation of the product is not possible.Batch history review: a lot number was not available.Explanation, rationale, conclusion and root cause: unfortunately, without the product we cannot determine the exact cause.According to the quality standard and dhr files, a material defect and a production error can most likely be excluded.Conclusion of statistical analysis: root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.

• Brand Name: SHAFT COMPL.D:10MM L:370MM
• Type of Device: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15699190
• MDR Text Key: 302695745
• Report Number: 9610612-2022-00331
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL536R
• Device Catalogue Number: PL536R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 34 YR